NCT03237156

Phase 1 TAK-906 Single and Multiple Ascending Dose Study in Japanese Healthy Male Participants

Completed Phase 1 Results posted Last updated 12 January 2021

What this trial tests

Phase 1 trial testing TAK-906 in Japanese Healthy Adult Male Participants in 24 participants. Completed in 7 October 2017.

Timeline

7 August 2017

Primary endpoint
7 October 2017

7 October 2017

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	other
Enrollment	24
Start date	7 August 2017
Primary completion	7 October 2017
Estimated completion	7 October 2017
Sites	1 location across Japan

Drugs / interventions tested

• TAK-906
• TAK-906 Placebo

Conditions studied

• Japanese Healthy Adult Male Participants — all drugs for Japanese Healthy Adult Male Participants →

Sponsor

Takeda — full company profile →

Who can join

Adults 20 to 60, male only, with Japanese Healthy Adult Male 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.

Number of Participants Who Experience at Least One Treatment-Emergent Adverse Event (TEAE) Primary · Baseline up to Day 14

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.

Group	Value	95% CI
Cohorts 1-3: Placebo	1
Cohort 1: TAK-906 50 mg	0
Cohort 2: TAK-906 100 mg	2
Cohort 3: TAK-906 10 mg	1

Number of Participants With Markedly Abnormal Values of Vital Signs Primary · Baseline up to Day 14

Reported data were numbers of participants who met markedly abnormal criteria of vital signs. Vital signs included body temperature, respiratory rate, blood pressure, and pulse. Vital signs collected were classified as markedly abnormal values if they met the following criteria: systolic blood pressure less than (\<) 85 millimeter of mercury (mmHg) or greater than (\>) 180 mmHg, diastolic blood pressure \<50 mmHg or \>110 mmHg, pulse \<50 beats per minute (bpm) or \>120 bpm, body temperature \<35.6 °C or \>37.7 °C.

Diastolic blood pressure <50 mmHg

Group	Value	95% CI
Cohorts 1-3: Placebo	2
Cohort 1: TAK-906 50 mg	1
Cohort 2: TAK-906 100 mg	2
Cohort 3: TAK-906 10 mg	1

Pulse < 50 bpm

Group	Value	95% CI
Cohorts 1-3: Placebo	3
Cohort 1: TAK-906 50 mg	2
Cohort 2: TAK-906 100 mg	2
Cohort 3: TAK-906 10 mg	2

Number of Participants With Markedly Abnormal Values of Clinical Laboratory Test Results Primary · Baseline up to Day 14

Reported data were numbers of participants who met markedly abnormal criteria of clinical laboratory test results. Clinical laboratory test results collected were classified as markedly abnormal values if they met the following criteria: red blood cells \<0.8×lower limit of normal (LLN) or \>1.2×upper limit of normal (ULN), platelets \<75×10\^3/μL or \>600×10\^3/μL, white blood cells \<0.5×LLN or \>1.5×ULN, protein (total) \<0.8×LLN or \>1.2×ULN, albumin \<2.5 g/dL, blood urea nitrogen \>30 mg/dL, uric acid \>13.0 mg/dL, creatinine \>2.0 mg/dL, total cholesterol \>300 mg/dL, triglycerides \>2.

Group	Value	95% CI
Cohorts 1-3: Placebo	0
Cohort 1: TAK-906 50 mg	0
Cohort 2: TAK-906 100 mg	0
Cohort 3: TAK-906 10 mg	0

Number of Participants With Markedly Abnormal Values of 12-lead Electrocardiogram (ECG) Primary · Baseline up to Day 8

Reported data were numbers of participants who met markedly abnormal criteria of 12-lead ECG. A standard 12-lead ECG was performed. The data collected was classified as markedly abnormal values if it met the following criteria: heart rate \<50 bpm or \>120 bpm, QT interval less than or equal to (\<=) 50 msec or greater than or equal to (\>=) 460 msec, QTcF interval \<=50 msec or either of the following conditions was met: observed value \>=500 msec, change from Day 1 Predose \>= 30 msec and observed value \>=450 msec.

Heart Rate <50 bpm

Group	Value	95% CI
Cohorts 1-3: Placebo	3
Cohort 1: TAK-906 50 mg	1
Cohort 2: TAK-906 100 mg	3
Cohort 3: TAK-906 10 mg	2

QT Interval >= 460 msec

Group	Value	95% CI
Cohorts 1-3: Placebo	1
Cohort 1: TAK-906 50 mg	0
Cohort 2: TAK-906 100 mg	0
Cohort 3: TAK-906 10 mg	0

Number of Participants With TEAEs Related to Physical Examinations Primary · Baseline up to Day 14

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with the treatment or study participation. A treatment-emergent adverse events (TEAE) is defined as an AE whose date of onset occurs on or after the start of study drug.

Group	Value	95% CI
Cohorts 1-3: Placebo	0
Cohort 1: TAK-906 50 mg	0
Cohort 2: TAK-906 100 mg	0
Cohort 3: TAK-906 10 mg	0

AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period Secondary · Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

AUC∞ is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 extrapolated to infinity, calculated using the observed value of the last quantifiable concentration.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	72.58	± 17.329
Cohort 2: TAK-906 100 mg	156.9	± 38.048
Cohort 3: TAK-906 10 mg	13.71	± 2.1631

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	7.869	± 2.1260
Cohort 2: TAK-906 100 mg	16.05	± 7.5395
Cohort 3: TAK-906 10 mg	1.602	± 0.46441

Cmax: Maximum Observed Plasma Concentration for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period Secondary · Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

Cmax is the peak plasma concentration of TAK-906 and its metabolite M23.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	35.31	± 12.255
Cohort 2: TAK-906 100 mg	58.21	± 28.491
Cohort 3: TAK-906 10 mg	6.951	± 2.0380

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	3.082	± 0.63298
Cohort 2: TAK-906 100 mg	4.412	± 3.0329
Cohort 3: TAK-906 10 mg	0.5088	± 0.28496

AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to Time Tau Over the Dosing Interval for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period Secondary · Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

AUCtau is a measure of total plasma exposure to TAK-906 and its Metabolite M23 from Time 0 to Time tau over the dosing interval.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	70.96	± 16.586
Cohort 2: TAK-906 100 mg	149.1	± 39.145
Cohort 3: TAK-906 10 mg	13.47	± 2.0130

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	7.608	± 1.8894
Cohort 2: TAK-906 100 mg	14.69	± 6.8520
Cohort 3: TAK-906 10 mg	1.327	± 0.60977

Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period Secondary · Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

Tmax is time to reach the peak plasma concentration of TAK-906 and its metabolite M23.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	1.000	1.00 – 2.00
Cohort 2: TAK-906 100 mg	1.000	0.500 – 3.00
Cohort 3: TAK-906 10 mg	1.000	1.00 – 1.50

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	1.000	1.00 – 2.00
Cohort 2: TAK-906 100 mg	1.000	1.00 – 4.00
Cohort 3: TAK-906 10 mg	1.000	1.00 – 1.50

t1/2z: Terminal Disposition Phase Half-life for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period Secondary · Day 1 pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, and 24 hours post-dose

t1/2z is time for the plasma concentration of TAK-906 and its metabolite M23 to decrease by half.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	4.692	± 3.8389
Cohort 2: TAK-906 100 mg	5.152	± 2.1478
Cohort 3: TAK-906 10 mg	1.894	± 0.85198

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	2.483	± 1.2160
Cohort 2: TAK-906 100 mg	4.423	± 3.0935
Cohort 3: TAK-906 10 mg	3.170	± 2.2826

Ae(0-24): Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Period Secondary · Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose

Ae(0-24) is the amount of TAK-906 and its metabolite M23 excreted in urine from Time 0 to 24 Hours postdose.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	741.2	± 114.12
Cohort 2: TAK-906 100 mg	1571	± 621.57
Cohort 3: TAK-906 10 mg	160.0	± 29.766

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	64.57	± 23.741
Cohort 2: TAK-906 100 mg	135.2	± 80.915
Cohort 3: TAK-906 10 mg	13.27	± 6.5007

Fe24: Fraction of Administered Dose of Drug Excreted in Urine From Time 0 to 24 Hours for TAK-906 and Its Metabolite M23 on Day 1 of Single Dose Secondary · Time Frame Day 1 pre-dose and 0-6, 6-12, and 12-24 hours post-dose

Fe24 was calculated as percentage of administered dose of drug excreted in urine from Time 0 to 24 Hours for TAK-906 and its metabolite M23.

TAK-906

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	1.815	± 0.27941
Cohort 2: TAK-906 100 mg	1.923	± 0.76094
Cohort 3: TAK-906 10 mg	1.959	± 0.36440

Metabolite M23

Group	Value	95% CI
Cohort 1: TAK-906 50 mg	0.1575	± 0.057901
Cohort 2: TAK-906 100 mg	0.1648	± 0.098672
Cohort 3: TAK-906 10 mg	0.1618	± 0.079274

Adverse events — posted to ClinicalTrials.gov

Time frame: TEAEs are adverse events that started after the first dose of double-blind study drug up to Day 14. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohorts 1-3: Placebo

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 1: TAK-906 50 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 2: TAK-906 100 mg

Serious: 0/6 (0%)

Deaths: 0/6

Cohort 3: TAK-906 10 mg

Serious: 0/6 (0%)

Deaths: 0/6

Other adverse events (5 terms — click to expand)

Reaction	System	Cohorts 1-3: Placebo	Cohort 1: TAK-906 50 mg	Cohort 2: TAK-906 100 mg	Cohort 3: TAK-906 10 mg
Pharyngitis	Infections and infestations	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—
Blood creatinine increased	Investigations	—	—	—	—
Blood lactate dehydrogenase increased	Investigations	—	—	—	—
Proteinuria	Renal and urinary disorders	—	—	—	—

Data from ClinicalTrials.gov NCT03237156 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple oral doses of TAK-906 in Japanese healthy male participants.

Publications & conference data

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