NCT02448719

Single-Dose Phase 1 Study of TAK-792

Completed Phase 1 Results posted Last updated 19 March 2019

What this trial tests

Phase 1 trial testing TAK-792 30 mg in Healthy Male Adults Participants in 72 participants. Completed in 28 January 2016.

Timeline

27 May 2015

Primary endpoint
28 January 2016

28 January 2016

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	72
Start date	27 May 2015
Primary completion	28 January 2016
Estimated completion	28 January 2016
Sites	1 location across Japan

Drugs / interventions tested

• TAK-792 30 mg — full drug profile →
• TAK-792 30 mg placebo
• TAK-792 100 mg — full drug profile →
• TAK-792 100 mg placebo
• TAK-792 250 mg — full drug profile →
• TAK-792 250 mg placebo
• TAK-792 500 mg
• TAK-792 500 mg placebo
• TAK-792 750 mg — full drug profile →
• TAK-792 750 mg placebo
• TAK-792 1250 mg — full drug profile →
• TAK-792 1250 mg placebo

Conditions studied

• Healthy Male Adults Participants — all drugs for Healthy Male Adults Participants →

Sponsor

Takeda — full company profile →

Who can join

Adults 20 to 45, male only, with Healthy Male Adults Participants. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) Primary · Baseline up to Day 8

Group	Value	95% CI
Cohort 1a-6a: Placebo	16.7
Cohort 1a: TAK-792 30 mg	16.7
Cohort 2a: TAK-792 100 mg	0.0
Cohort 3a: TAK-792 250 mg	33.3
Cohort 4a-1: TAK-792 500 mg	0.0
Cohort 5a-1: TAK-792 750 mg	16.7
Cohort 6a: TAK-792 1250 mg	0.0
Cohort 4a-2: Placebo	0.0
Cohort 4a-2: TAK-792 500 mg	0.0
Cohort 5a-2: Placebo	0.0
Cohort 5a-2: TAK-792 750 mg	0.0
Cohort 4b-1 - 6b: Placebo	50.0

Number of Participants With TEAE Related to Vital Signs Primary · Baseline up to Day 5

Vital signs included body temperature (infra-axillary measurement), supine blood pressure (systolic and diastolic) after the participant has rested for at least 5 minutes, respiratory rate, and pulse (beats per minute \[bpm\]).

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Number of Participants With TEAE Related to Body Weight Primary · Baseline up to Day 5

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Number of Participants With TEAE Related to Electrocardiograms (ECG) Primary · Baseline up to Day 5

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Number of Participants With TEAEs Related to Laboratory Tests Primary · Baseline up to Day 5

Reported TEAE Related to Laboratory Tests are following; Occult blood positive, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood bilirubin increased, Blood creatine phosphokinase increased, Blood glucose increased, Blood triglycerides increased, Blood urine present, Protein urine present, and White blood cell count increased.

Occult blood positive

Group	Value	95% CI
Cohort 1a-6a: Placebo	2
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Alanine aminotransferase increased

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Aspartate aminotransferase increased

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Blood bilirubin increased

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Blood creatine phosphokinase increased

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	1
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Blood glucose increased

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	1

Blood triglycerides increased

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	1

Blood urine present

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Number of Participants With TEAE Related to Gastrointestinal Symptom Rating Scale (GSRS) Primary · Baseline up to Day 5

The gastrointestinal (GI) symptoms (abdominal pain, heartburn, acid regurgitation, hunger pains, nausea, borborygmus, abdominal distension, eructation, increased flatus, constipation, diarrhoea, loose stools, hard stools, urgent need for defecation, and feeling of incomplete evacuation) using GSRS questionnaires at each assessment point. The GSRS a 15-item self-administered questionnaire that assesses the impact of GI symptoms during the past week on a scale from 1 (no discomfort at all) to 7 (very severe discomfort). Possible overall scores range from 1 to 7, with lower scores indicating a be

Diarrhoea

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	1
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	1

Constipation

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	0

Faeces hard

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	1

Faeces soft

Group	Value	95% CI
Cohort 1a-6a: Placebo	0
Cohort 1a: TAK-792 30 mg	0
Cohort 2a: TAK-792 100 mg	0
Cohort 3a: TAK-792 250 mg	0
Cohort 4a-1: TAK-792 500 mg	0
Cohort 5a-1: TAK-792 750 mg	0
Cohort 6a: TAK-792 1250 mg	0
Cohort 4a-2: Placebo	0
Cohort 4a-2: TAK-792 500 mg	0
Cohort 5a-2: Placebo	0
Cohort 5a-2: TAK-792 750 mg	0
Cohort 4b-1 - 6b: Placebo	1

AUC(0-96): Area Under the Plasma Concentration-time Curve From Time 0 to 96 Hours Postdose for TAK-792F and Its Metabolites M-I and M-II Secondary · Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose

TAK-792F

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	47.34	± 24.7
Cohort 2a: TAK-792 100 mg	350.0	± 15.7
Cohort 3a: TAK-792 250 mg	521.3	± 24.6
Cohort 4a-1: TAK-792 500 mg	770.6	± 36.4
Cohort 5a-1: TAK-792 750 mg	998.5	± 53.2
Cohort 6a: TAK-792 1250 mg	1988.0	± 40.8
Cohort 4a-2: TAK-792 500 mg	357.2	± 44.5
Cohort 5a-2: TAK-792 750 mg	898.6	± 28.5
Cohort 4b-1: TAK-792 500 mg	610.5	± 28.3
Cohort 5b-1: TAK-792 750 mg	622.5	± 51.8
Cohort 6b: TAK-792 1250 mg	557.0	± 53.9
Cohort 4b-2: TAK-792 500 mg	485.6	± 31.5

M-I

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	6.765	± 25.9
Cohort 2a: TAK-792 100 mg	84.01	± 40.8
Cohort 3a: TAK-792 250 mg	63.94	± 51.7
Cohort 4a-1: TAK-792 500 mg	128.1	± 27.7
Cohort 5a-1: TAK-792 750 mg	167.6	± 43.1
Cohort 6a: TAK-792 1250 mg	424.2	± 41.9
Cohort 4a-2: TAK-792 500 mg	79.70	± 34.2
Cohort 5a-2: TAK-792 750 mg	190.5	± 51.3
Cohort 4b-1: TAK-792 500 mg	133.6	± 39.5
Cohort 5b-1: TAK-792 750 mg	224.0	± 34.7
Cohort 6b: TAK-792 1250 mg	407.9	± 40.7
Cohort 4b-2: TAK-792 500 mg	97.17	± 36.6

M-II

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	422.5	± 22.1
Cohort 2a: TAK-792 100 mg	1324.0	± 45.7
Cohort 3a: TAK-792 250 mg	2658.0	± 57.9
Cohort 4a-1: TAK-792 500 mg	3192.0	± 56.3
Cohort 5a-1: TAK-792 750 mg	4909.0	± 56.2
Cohort 6a: TAK-792 1250 mg	5086.0	± 78.9
Cohort 4a-2: TAK-792 500 mg	3237.0	± 66.9
Cohort 5a-2: TAK-792 750 mg	5483.0	± 54.8
Cohort 4b-1: TAK-792 500 mg	4824.0	± 38.4
Cohort 5b-1: TAK-792 750 mg	6261.0	± 51.1
Cohort 6b: TAK-792 1250 mg	15430.0	± 26.7
Cohort 4b-2: TAK-792 500 mg	4813.0	± 32.9

AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-792F and Its Metabolites M-I and M-II Secondary · Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose

TAK-792F

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	46.45	± 24.2
Cohort 2a: TAK-792 100 mg	346.6	± 15.4
Cohort 3a: TAK-792 250 mg	517.4	± 24.8
Cohort 4a-1: TAK-792 500 mg	767.8	± 36.6
Cohort 5a-1: TAK-792 750 mg	995.9	± 53.4
Cohort 6a: TAK-792 1250 mg	1980.0	± 41.0
Cohort 4a-2: TAK-792 500 mg	356.2	± 44.6
Cohort 5a-2: TAK-792 750 mg	891.9	± 28.7
Cohort 4b-1: TAK-792 500 mg	608.4	± 28.4
Cohort 5b-1: TAK-792 750 mg	619.2	± 51.8
Cohort 6b: TAK-792 1250 mg	554.9	± 54.1
Cohort 4b-2: TAK-792 500 mg	481.9	± 31.8

M-I

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	5.912	± 31.6
Cohort 2a: TAK-792 100 mg	80.78	± 39.6
Cohort 3a: TAK-792 250 mg	61.32	± 52.1
Cohort 4a-1: TAK-792 500 mg	119.6	± 22.4
Cohort 5a-1: TAK-792 750 mg	160.5	± 42.8
Cohort 6a: TAK-792 1250 mg	388.6	± 43.3
Cohort 4a-2: TAK-792 500 mg	74.37	± 34.7
Cohort 5a-2: TAK-792 750 mg	182.1	± 53.2
Cohort 4b-1: TAK-792 500 mg	127.6	± 41.4
Cohort 5b-1: TAK-792 750 mg	214.3	± 36.5
Cohort 6b: TAK-792 1250 mg	386.8	± 42.4
Cohort 4b-2: TAK-792 500 mg	92.89	± 37.9

M-II

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	392.0	± 24.3
Cohort 2a: TAK-792 100 mg	1246.0	± 46.0
Cohort 3a: TAK-792 250 mg	2302.0	± 57.0
Cohort 4a-1: TAK-792 500 mg	3039.0	± 52.9
Cohort 5a-1: TAK-792 750 mg	4470.0	± 59.3
Cohort 6a: TAK-792 1250 mg	4352.0	± 71.2
Cohort 4a-2: TAK-792 500 mg	3193.0	± 68.0
Cohort 5a-2: TAK-792 750 mg	5319.0	± 56.3
Cohort 4b-1: TAK-792 500 mg	4554.0	± 41.2
Cohort 5b-1: TAK-792 750 mg	6030.0	± 54.0
Cohort 6b: TAK-792 1250 mg	15430.0	± 26.7
Cohort 4b-2: TAK-792 500 mg	4683.0	± 34.9

Cmax: Maximum Observed Plasma Concentration for TAK-792F and Its Metabolites M-I and M-II Secondary · Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose

TAK-792F

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	8.916	± 24.2
Cohort 2a: TAK-792 100 mg	59.17	± 29.7
Cohort 3a: TAK-792 250 mg	85.12	± 21.1
Cohort 4a-1: TAK-792 500 mg	113.2	± 62.9
Cohort 5a-1: TAK-792 750 mg	140.6	± 52.6
Cohort 6a: TAK-792 1250 mg	267.5	± 51.8
Cohort 4a-2: TAK-792 500 mg	57.85	± 48.7
Cohort 5a-2: TAK-792 750 mg	136.4	± 40.8
Cohort 4b-1: TAK-792 500 mg	88.44	± 19.8
Cohort 5b-1: TAK-792 750 mg	97.62	± 59.3
Cohort 6b: TAK-792 1250 mg	96.99	± 47.0
Cohort 4b-2: TAK-792 500 mg	72.22	± 38.2

M-I

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	1.707	± 30.8
Cohort 2a: TAK-792 100 mg	13.40	± 21.5
Cohort 3a: TAK-792 250 mg	8.786	± 29.9
Cohort 4a-1: TAK-792 500 mg	14.0	± 17.1
Cohort 5a-1: TAK-792 750 mg	17.13	± 42.6
Cohort 6a: TAK-792 1250 mg	37.54	± 51.4
Cohort 4a-2: TAK-792 500 mg	8.401	± 34.5
Cohort 5a-2: TAK-792 750 mg	21.92	± 49.3
Cohort 4b-1: TAK-792 500 mg	14.65	± 31.7
Cohort 5b-1: TAK-792 750 mg	21.73	± 34.7
Cohort 6b: TAK-792 1250 mg	25.15	± 28.8
Cohort 4b-2: TAK-792 500 mg	12.86	± 24.5

M-II

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	27.36	± 58.9
Cohort 2a: TAK-792 100 mg	87.07	± 57.9
Cohort 3a: TAK-792 250 mg	110.4	± 70.4
Cohort 4a-1: TAK-792 500 mg	105.2	± 19.1
Cohort 5a-1: TAK-792 750 mg	187.2	± 24.0
Cohort 6a: TAK-792 1250 mg	213.6	± 60.6
Cohort 4a-2: TAK-792 500 mg	150.2	± 27.1
Cohort 5a-2: TAK-792 750 mg	218.9	± 60.3
Cohort 4b-1: TAK-792 500 mg	134.7	± 33.4
Cohort 5b-1: TAK-792 750 mg	193.7	± 25.4
Cohort 6b: TAK-792 1250 mg	307.5	± 10.5
Cohort 4b-2: TAK-792 500 mg	186.4	± 42.0

Tmax: Time to Reach the Cmax for TAK-792F and Its Metabolites M-I and M-II Secondary · Day 1: pre-dose and at multiple timepoints (0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose

TAK-792F

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	1.7500	1.500 – 4.000
Cohort 2a: TAK-792 100 mg	2.5000	1.500 – 4.000
Cohort 3a: TAK-792 250 mg	2.5000	1.500 – 4.000
Cohort 4a-1: TAK-792 500 mg	2.0000	1.500 – 4.000
Cohort 5a-1: TAK-792 750 mg	4.0000	3.000 – 4.000
Cohort 6a: TAK-792 1250 mg	4.0000	3.000 – 6.000
Cohort 4a-2: TAK-792 500 mg	3.0000	1.000 – 4.000
Cohort 5a-2: TAK-792 750 mg	3.5000	3.000 – 4.000
Cohort 4b-1: TAK-792 500 mg	3.0000	3.000 – 6.000
Cohort 5b-1: TAK-792 750 mg	4.0000	3.000 – 4.000
Cohort 6b: TAK-792 1250 mg	3.5000	2.000 – 4.000
Cohort 4b-2: TAK-792 500 mg	3.0000	1.500 – 8.000

M-I

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	1.5000	1.000 – 3.000
Cohort 2a: TAK-792 100 mg	2.0000	1.500 – 8.000
Cohort 3a: TAK-792 250 mg	1.7500	1.500 – 4.000
Cohort 4a-1: TAK-792 500 mg	6.0000	1.500 – 8.000
Cohort 5a-1: TAK-792 750 mg	3.5000	1.500 – 8.000
Cohort 6a: TAK-792 1250 mg	4.0000	3.000 – 8.000
Cohort 4a-2: TAK-792 500 mg	3.0000	1.500 – 6.000
Cohort 5a-2: TAK-792 750 mg	3.5000	3.000 – 16.000
Cohort 4b-1: TAK-792 500 mg	2.5000	1.000 – 6.000
Cohort 5b-1: TAK-792 750 mg	5.0000	1.000 – 8.000
Cohort 6b: TAK-792 1250 mg	6.0000	2.000 – 10.000
Cohort 4b-2: TAK-792 500 mg	4.0000	2.000 – 8.000

M-II

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	9.0000	6.000 – 12.000
Cohort 2a: TAK-792 100 mg	11.0000	8.000 – 24.000
Cohort 3a: TAK-792 250 mg	14.0000	10.000 – 24.000
Cohort 4a-1: TAK-792 500 mg	16.0000	12.000 – 24.000
Cohort 5a-1: TAK-792 750 mg	30.0000	8.000 – 48.000
Cohort 6a: TAK-792 1250 mg	24.0000	24.000 – 48.000
Cohort 4a-2: TAK-792 500 mg	24.0000	10.000 – 24.000
Cohort 5a-2: TAK-792 750 mg	16.0000	16.000 – 24.000
Cohort 4b-1: TAK-792 500 mg	24.0000	12.000 – 24.000
Cohort 5b-1: TAK-792 750 mg	20.0000	16.000 – 36.000
Cohort 6b: TAK-792 1250 mg	42.0000	24.000 – 48.000
Cohort 4b-2: TAK-792 500 mg	16.0000	10.000 – 24.000

Urinary Excretion Ratio of TAK-792F and Its Metabolites M-I and M-II as Percentage of TAK-792 Dose From 0 to 96 Hours Postdose Secondary · Day 1: pre-dose and at multiple timepoints (6, 12, 24, 36, 48, 72, 96 hours post dose; up to 96 hours) post-dose

TAK-792F

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	0.4903	1.500 – 4.000
Cohort 2a: TAK-792 100 mg	1.0367	1.500 – 4.000
Cohort 3a: TAK-792 250 mg	0.6143	1.500 – 4.000
Cohort 4a-1: TAK-792 500 mg	0.5128	1.500 – 4.000
Cohort 5a-1: TAK-792 750 mg	0.4733	3.000 – 4.000
Cohort 6a: TAK-792 1250 mg	0.5477	3.000 – 6.000
Cohort 4a-2: TAK-792 500 mg	0.2500	1.000 – 4.000
Cohort 5a-2: TAK-792 750 mg	0.4484	3.000 – 4.000
Cohort 4b-1: TAK-792 500 mg	0.3955	3.000 – 6.000
Cohort 5b-1: TAK-792 750 mg	0.2830	3.000 – 4.000
Cohort 6b: TAK-792 1250 mg	0.1715	2.000 – 4.000
Cohort 4b-2: TAK-792 500 mg	0.2755	1.500 – 8.000

M-I

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	1.5667	1.000 – 3.000
Cohort 2a: TAK-792 100 mg	1.9150	1.500 – 8.000
Cohort 3a: TAK-792 250 mg	1.8183	1.500 – 4.000
Cohort 4a-1: TAK-792 500 mg	1.4910	1.500 – 8.000
Cohort 5a-1: TAK-792 750 mg	0.9552	1.500 – 8.000
Cohort 6a: TAK-792 1250 mg	1.2642	3.000 – 8.000
Cohort 4a-2: TAK-792 500 mg	0.6604	1.500 – 6.000
Cohort 5a-2: TAK-792 750 mg	1.0155	3.000 – 16.000
Cohort 4b-1: TAK-792 500 mg	1.3317	1.000 – 6.000
Cohort 5b-1: TAK-792 750 mg	1.1630	1.000 – 8.000
Cohort 6b: TAK-792 1250 mg	1.1442	2.000 – 10.000
Cohort 4b-2: TAK-792 500 mg	0.6330	2.000 – 8.000

M-II

Group	Value	95% CI
Cohort 1a: TAK-792 30 mg	52.2833	6.000 – 12.000
Cohort 2a: TAK-792 100 mg	25.4567	8.000 – 24.000
Cohort 3a: TAK-792 250 mg	35.1333	10.000 – 24.000
Cohort 4a-1: TAK-792 500 mg	21.9300	12.000 – 24.000
Cohort 5a-1: TAK-792 750 mg	18.1750	8.000 – 48.000
Cohort 6a: TAK-792 1250 mg	15.2100	24.000 – 48.000
Cohort 4a-2: TAK-792 500 mg	20.0120	10.000 – 24.000
Cohort 5a-2: TAK-792 750 mg	24.9333	16.000 – 24.000
Cohort 4b-1: TAK-792 500 mg	31.8350	12.000 – 24.0000
Cohort 5b-1: TAK-792 750 mg	24.4667	16.000 – 36.000
Cohort 6b: TAK-792 1250 mg	39.4167	24.000 – 48.000
Cohort 4b-2: TAK-792 500 mg	22.5383	10.000 – 24.000

AUC(0-2.5): Area Under the Plasma Concentration-time Curve From Time 0 to 2.5 Hours Postdose for Total Branched Chain Amino Acids (BCAA) Parameter in Cohorts 4a-2, 4b-2, 5a-2 and 5b-2 Secondary · Day -1: pre-dose and Day 1 (2.5 hours post dose)

Day-1: Total BCAA

Group	Value	95% CI
Cohort 4a-2: Placebo	1257.10	± 111.299
Cohort 4a-2: TAK-792 500 mg	1372.16	± 62.857
Cohort 4b-2: Placebo	1125.05	± 90.156
Cohort 4b-2: TAK-792 500 mg	1102.43	± 243.948
Cohort 5a-2: Placebo	1879.40	± 534.007
Cohort 5a-2: TAK-792 750 mg	2124.73	± 181.829
Cohort 5b-2: Placebo	2011.75	± 357.018
Cohort 5b-2: TAK-792 750 mg	1982.10	± 149.745

Day 1: Total BCAA

Group	Value	95% CI
Cohort 4a-2: Placebo	1329.80	± 64.912
Cohort 4a-2: TAK-792 500 mg	1272.66	± 84.565
Cohort 4b-2: Placebo	1305.40	± 172.393
Cohort 4b-2: TAK-792 500 mg	1072.87	± 178.282
Cohort 5a-2: Placebo	2307.80	± 568.514
Cohort 5a-2: TAK-792 750 mg	1685.08	± 163.129
Cohort 5b-2: Placebo	2354.00	± 433.174
Cohort 5b-2: TAK-792 750 mg	1665.75	± 119.524

Adverse events — posted to ClinicalTrials.gov

Time frame: Treatment-emergent adverse events are adverse events that started after the first dose of double-blind study drug and up to Day 8.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1a-6a: Placebo

Serious: 0/12 (0%)

Deaths: —

Cohort 1a: TAK-792 30 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 2a: TAK-792 100 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 3a: TAK-792 250 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 4a-1: TAK-792 500 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 5a-1: TAK-792 750 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 6a: TAK-792 1250 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 4a-2: Placebo

Serious: 0/2 (0%)

Deaths: —

Cohort 4a-2: TAK-792 500 mg

Serious: 0/5 (0%)

Deaths: —

Cohort 5a-2: Placebo

Serious: 0/2 (0%)

Deaths: —

Cohort 5a-2: TAK-792 750 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 4b-1 - 6b: Placebo

Serious: 0/6 (0%)

Deaths: —

Cohort 4b-1: TAK-792 500 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 5b-1: TAK-792 750 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 6b: TAK-792 1250 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 4b-2: Placebo

Serious: 0/2 (0%)

Deaths: —

Cohort 4b-2: TAK-792 500 mg

Serious: 0/6 (0%)

Deaths: —

Cohort 5b-2: Placebo

Serious: 0/2 (0%)

Deaths: —

Cohort 5b-2: TAK-792 750 mg

Serious: 0/6 (0%)

Deaths: —

Other adverse events (18 terms — click to expand)

Reaction	System	Cohort 1a-6a: Placebo	Cohort 1a: TAK-792 30 mg	Cohort 2a: TAK-792 100 mg	Cohort 3a: TAK-792 250 mg	Cohort 4a-1: TAK-792 500 mg	Cohort 5a-1: TAK-792 750 mg	Cohort 6a: TAK-792 1250 mg	Cohort 4a-2: Placebo	Cohort 4a-2: TAK-792 500 mg	Cohort 5a-2: Placebo	Cohort 5a-2: TAK-792 750 mg	Cohort 4b-1 - 6b: Placebo	Cohort 4b-1: TAK-792 500 mg	Cohort 5b-1: TAK-792 750 mg	Cohort 6b: TAK-792 1250 mg	Cohort 4b-2: Placebo	Cohort 4b-2: TAK-792 500 mg	Cohort 5b-2: Placebo	Cohort 5b-2: TAK-792 750 mg
Occult blood positive	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Faeces hard	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Faeces soft	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood bilirubin increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood glucose increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood triglycerides increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Blood urine present	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Protein urine present	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
White blood cell count increased	Investigations	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Data from ClinicalTrials.gov NCT02448719 adverse events section.

Sponsor's own description

The purpose of this study is to characterize the safety and tolerability profile of TAK-792 when administered as a single oral dose in healthy Japanese and Caucasian male participants.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.