NCT02706834 is a Phase 1 clinical trial of TAK-828 in Dose Finding Study, sponsored by Takeda.

Who is sponsoring NCT02706834?

NCT02706834 is sponsored by Takeda.

What drugs are being tested in NCT02706834?

Interventions in NCT02706834: TAK-828, Placebo.

What condition does NCT02706834 study?

NCT02706834 studies Dose Finding Study.

Is NCT02706834 still recruiting?

NCT02706834 is currently completed. Last updated 19 October 2018.

Are results published for NCT02706834?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-10-19 · How we verify

NCT02706834

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety, Tolerability and Pharmacokinetics of Escalating Single Doses of TAK-828 in Healthy Participants

Completed Phase 1 Results posted Last updated 19 October 2018

What this trial tests

Phase 1 trial testing TAK-828 in Dose Finding Study in 36 participants. Completed in 17 June 2016.

Timeline

1 March 2016

Primary endpoint
17 June 2016

17 June 2016

Quick facts

Lead sponsor	Takeda
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	other
Enrollment	36
Start date	1 March 2016
Primary completion	17 June 2016
Estimated completion	17 June 2016
Sites	2 locations across United States

Drugs / interventions tested

TAK-828 — full drug profile →
Placebo

Conditions studied

Dose Finding Study — all drugs for Dose Finding Study →

Sponsor

Takeda — full company profile →

Who can join

Adults 18 to 55, any sex, with Dose Finding Study. 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 Experienced at Least 1 Treatment-Emergent Adverse Event (TEAE) Primary · Day 1 up to 30 days after last dose of study drug (up to 85 days)

An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.

Group	Value	95% CI
Cohort 1: Placebo	30.0
Cohort 1: TAK-828 0.1 mg/ Fasted	55.6
Cohort 1: TAK-828 0.5 mg/ Fasted	37.5
Cohort 1: TAK-828 15 mg/ Fasted	14.3
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	12.5
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	11.1
Cohort 2: TAK-828 50 mg/ Fasted	11.1
Cohort 2: TAK-828 200 mg/ Fasted	11.1
Cohort 2: TAK-828 100 mg/ Fasted	22.2
Cohort 2: TAK-828 100 mg/ Fed	0

Cmax: Maximum Observed Plasma Concentration for TAK-828F (Free Base of TAK-828) Secondary · Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose

Group	Value	95% CI
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants	5.96	± 0.982
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants	38.6	± 3.56
TAK-828 3 mg/ Fasted in Non-Japanese Participants	247	± 28.7
TAK-828 15 mg/ Fasted in Non-Japanese Participants	1150	± 201
TAK-828 50 mg/ Fasted in Non-Japanese Participants	4820	± 1090
TAK-828 100 mg/ Fasted in Non-Japanese Participants	8900	± 1870
TAK-828 100 mg/ Fed in Non-Japanese Participants	3730	± 850
TAK-828 200 mg/ Fasted in Non-Japanese Participants	18400	± 2950
TAK-828 15 mg/ Fasted in Japanese Participants	1400	± 114
TAK-828 100 mg/ Fasted in Japanese Participants	9530	± 1030
TAK-828 150 mg/ Fasted in Japanese Participants	14300	± 2470

Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE) Primary · Day 1 up to 30 days after last dose of study drug (up to 85 days)

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	11.1
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety Laboratory Tests at Least Once Post-dose Primary · Day 1 up to 7 days after last dose of study drug (up to 52 days)

Hematology and Chemistry values that met the following criteria were considered to be markedly abnormal: Erythrocytes, Hematocrit and Hemoglobin \<0.8\*Lower Limit of Normal (LLN) or \>1.2\*Upper Limit of Normal ULN.; Leukocytes \<0.5\*LLN or \>1.5\*ULN; Platelet \<75 or \>600 10\^9/liter (L). Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma Glutamyl Transferase \>3\*ULN; Albumin \<25 g/L; Bilirubin \> 34.2 umol/L; Blood Urea Nitrogen \>10.7 mmol/L; Chloride \<75 or \>126 mmol/L; Creatinine \>177 umol/L; Direct Bilirubin \>2\*ULN; Glucose \<2.8 or \>19.4 mmol

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	0
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Vital Sign Measurements at Least Once Post-dose Primary · Day 1 up to 7 days after last dose of study drug (up to 52 days)

Vital signs measurements that met the following criteria were considered to be markedly abnormal: Systolic Blood Pressure (SBP) \<85 mmHg or \>180 mmHg supine laying face upward) or standing; Diastolic Blood Pressure (DBP) \<50 mmHg or \>110 mmHg supine or standing; Pulse Rate (PR) \<50 beats/minute (bpm) or \>120 bpm supine or standing; Temperature \<35.6 degrees Celsius (C) or \>37.7 degrees C.

SBP <85 mmHg: standing, after 1 minute

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	0
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	12.5
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	11.1
Cohort 2: TAK-828 100 mg/ Fed	0

SBP <85 mmHg: standing, after 3 minutes

Group	Value	95% CI
Cohort 1: Placebo	20.0
Cohort 1: TAK-828 0.1 mg/ Fasted	11.1
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	11.1
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	11.1
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

DBP <50 mmHg: supine, after 5 minutes

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	0
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	14.3
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	11.1
Cohort 2: TAK-828 50 mg/ Fasted	11.1
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

DBP <50 mmHg: standing, after 3 minutes

Group	Value	95% CI
Cohort 1: Placebo	10.0
Cohort 1: TAK-828 0.1 mg/ Fasted	11.1
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	11.1
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

PR <50 bpm: supine, after 5 minutes

Group	Value	95% CI
Cohort 1: Placebo	20.0
Cohort 1: TAK-828 0.1 mg/ Fasted	22.2
Cohort 1: TAK-828 0.5 mg/ Fasted	25.0
Cohort 1: TAK-828 15 mg/ Fasted	14.3
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	25.0
Cohort 2: Placebo	33.3
Cohort 2: TAK-828 3 mg/ Fasted	22.2
Cohort 2: TAK-828 50 mg/ Fasted	22.2
Cohort 2: TAK-828 200 mg/ Fasted	22.2
Cohort 2: TAK-828 100 mg/ Fasted	22.2
Cohort 2: TAK-828 100 mg/ Fed	50.0

PR <50 bpm: standing, after 1 minute

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	0
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	11.1
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

PR >120 bpm: standing, after 1 minute

Group	Value	95% CI
Cohort 1: Placebo	20.0
Cohort 1: TAK-828 0.1 mg/ Fasted	11.1
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	28.6
Cohort 1: TAK-828 100 mg/ Fed	12.5
Cohort 2: Placebo	11.1
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	11.1
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

PR <50 bpm: standing, after 3 minutes

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	0
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	0
Cohort 2: Placebo	11.1
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

Percentage of Participants Who Meet the Markedly Abnormal Criteria for Safety 12-lead Electrocardiogram (ECG) Measurements at Least Once Post-dose Primary · Day 1 up to 7 days after last dose of study drug (up to 52 days)

Heart Rate \<50 beats per minute (bpm) \>120 bpm; QTcB (Bazett's Correction Formula) ≤50 milliseconds (msec) or ≥500 msec OR ≥30 msec change from Baseline and ≥450 msec; QTcF (Fridericia's Correction Formula) ≤50 msec or ≥500 msec OR ≥30 msec change from Baseline (CFB) and ≥450 msec.

Heart Rate <50 bpm

Group	Value	95% CI
Cohort 1: Placebo	20.0
Cohort 1: TAK-828 0.1 mg/ Fasted	33.3
Cohort 1: TAK-828 0.5 mg/ Fasted	25.0
Cohort 1: TAK-828 15 mg/ Fasted	28.6
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	25.0
Cohort 2: Placebo	44.4
Cohort 2: TAK-828 3 mg/ Fasted	33.3
Cohort 2: TAK-828 50 mg/ Fasted	33.3
Cohort 2: TAK-828 200 mg/ Fasted	33.3
Cohort 2: TAK-828 100 mg/ Fasted	55.6
Cohort 2: TAK-828 100 mg/ Fed	50.0

QTcB: ≥500 msec OR ≥30 msec CFB and ≥450 msec

Group	Value	95% CI
Cohort 1: Placebo	0
Cohort 1: TAK-828 0.1 mg/ Fasted	0
Cohort 1: TAK-828 0.5 mg/ Fasted	0
Cohort 1: TAK-828 15 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fasted	0
Cohort 1: TAK-828 100 mg/ Fed	25.0
Cohort 2: Placebo	0
Cohort 2: TAK-828 3 mg/ Fasted	0
Cohort 2: TAK-828 50 mg/ Fasted	0
Cohort 2: TAK-828 200 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fasted	0
Cohort 2: TAK-828 100 mg/ Fed	0

Tmax: Time of First Occurrence of Cmax for TAK-828F (Free Base of TAK-828) Secondary · Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose

Group	Value	95% CI
TAK-828 0.1 mg/ Fasted in Non-Japanese Participants	1.00	0.500 – 1.13
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants	1.00	0.517 – 2.00
TAK-828 3 mg/ Fasted in Non-Japanese Participants	1.00	0.500 – 1.00
TAK-828 15 mg/ Fasted in Non-Japanese Participants	1.00	1.00 – 1.50
TAK-828 50 mg/ Fasted in Non-Japanese Participants	1.00	0.500 – 1.50
TAK-828 100 mg/ Fasted in Non-Japanese Participants	1.00	0.500 – 1.02
TAK-828 100 mg/ Fed in Non-Japanese Participants	3.50	1.00 – 4.00
TAK-828 200 mg/ Fasted in Non-Japanese Participants	1.00	0.500 – 1.00
TAK-828 15 mg/ Fasted in Japanese Participants	1.00	0.500 – 2.00
TAK-828 100 mg/ Fasted in Japanese Participants	1.00	0.500 – 1.50
TAK-828 150 mg/ Fasted in Japanese Participants	1.00	0.500 – 1.03

t1/2z: Terminal Disposition Phase Half-Life for TAK-828F (Free Base of TAK-828) Secondary · Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose

Group	Value	95% CI
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants	5.38	± 0.568
TAK-828 3 mg/ Fasted in Non-Japanese Participants	4.94	± 1.11
TAK-828 15 mg/ Fasted in Non-Japanese Participants	6.53	± 1.14
TAK-828 50 mg/ Fasted in Non-Japanese Participants	7.51	± 1.95
TAK-828 100 mg/ Fasted in Non-Japanese Participants	7.53	± 1.32
TAK-828 100 mg/ Fed in Non-Japanese Participants	7.04	± 0.701
TAK-828 200 mg/ Fasted in Non-Japanese Participants	7.97	± 1.42
TAK-828 15 mg/ Fasted in Japanese Participants	6.71	± 1.37
TAK-828 100 mg/ Fasted in Japanese Participants	6.71	± 0.950
TAK-828 150 mg/ Fasted in Japanese Participants	6.44	± 0.406

AUC∞: Area Under the Concentration-Time Curve From Time 0 to Infinity Calculated Using the Observed Value of the Last Quantifiable Concentration for TAK-828F (Free Base of TAK-828) Secondary · Day 1 pre-dose and at multiple timepoints (up to 72 hours) post-dose

Group	Value	95% CI
TAK-828 0.5 mg/ Fasted in Non-Japanese Participants	214	± 30.4
TAK-828 3 mg/ Fasted in Non-Japanese Participants	1150	± 211
TAK-828 15 mg/ Fasted in Non-Japanese Participants	5930	± 1430
TAK-828 50 mg/ Fasted in Non-Japanese Participants	23100	± 5400
TAK-828 100 mg/ Fasted in Non-Japanese Participants	45400	± 10300
TAK-828 100 mg/ Fed in Non-Japanese Participants	38000	± 7370
TAK-828 200 mg/ Fasted in Non-Japanese Participants	106000	± 20800
TAK-828 15 mg/ Fasted in Japanese Participants	8560	± 1610
TAK-828 100 mg/ Fasted in Japanese Participants	54600	± 13400
TAK-828 150 mg/ Fasted in Japanese Participants	83700	± 16400

Adverse events — posted to ClinicalTrials.gov

Time frame: From Day 1 up to 30 days after last dose of study drug (up to 85 days).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cohort 1: Placebo

Serious: 0/10 (0%)

Deaths: —

Cohort 1: TAK-828 0.1 mg/ Fasted

Serious: 1/9 (11%)

Deaths: —

Cohort 1: TAK-828 0.5 mg/ Fasted

Serious: 0/8 (0%)

Deaths: —

Cohort 1: TAK-828 15 mg/ Fasted

Serious: 0/7 (0%)

Deaths: —

Cohort 1: TAK-828 100 mg/ Fasted

Serious: 0/7 (0%)

Deaths: —

Cohort 1: TAK-828 100 mg/ Fed

Serious: 0/8 (0%)

Deaths: —

Cohort 2: Placebo

Serious: 0/9 (0%)

Deaths: —

Cohort 2: TAK-828 3 mg/ Fasted

Serious: 0/9 (0%)

Deaths: —

Cohort 2: TAK-828 50 mg/ Fasted

Serious: 0/9 (0%)

Deaths: —

Cohort 2: TAK-828 200 mg/ Fasted

Serious: 0/9 (0%)

Deaths: —

Cohort 2: TAK-828 100 mg/ Fasted

Serious: 0/9 (0%)

Deaths: —

Cohort 2: TAK-828 100 mg/ Fed

Serious: 0/4 (0%)

Deaths: —

Cohort 3: Placebo

Serious: 0/12 (0%)

Deaths: —

Cohort 3: TAK-828 15 mg/ Fasted

Serious: 0/8 (0%)

Deaths: —

Cohort 3: TAK-828 100 mg/ Fasted

Serious: 0/8 (0%)

Deaths: —

Cohort 3: TAK-828 150 mg/ Fasted

Serious: 0/6 (0%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	Cohort 1: Placebo	Cohort 1: TAK-828 0.1 mg/ …	Cohort 1: TAK-828 0.5 mg/ …	Cohort 1: TAK-828 15 mg/ F…	Cohort 1: TAK-828 100 mg/ …	Cohort 1: TAK-828 100 mg/ …	Cohort 2: Placebo	Cohort 2: TAK-828 3 mg/ Fa…	Cohort 2: TAK-828 50 mg/ F…	Cohort 2: TAK-828 200 mg/ …	Cohort 2: TAK-828 100 mg/ …	Cohort 2: TAK-828 100 mg/ …	Cohort 3: Placebo	Cohort 3: TAK-828 15 mg/ F…	Cohort 3: TAK-828 100 mg/ …	Cohort 3: TAK-828 150 mg/ …
Ventricular tachycardia	Cardiac disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Other adverse events (25 terms — click to expand)

Reaction	System	Cohort 1: Placebo	Cohort 1: TAK-828 0.1 mg/ …	Cohort 1: TAK-828 0.5 mg/ …	Cohort 1: TAK-828 15 mg/ F…	Cohort 1: TAK-828 100 mg/ …	Cohort 1: TAK-828 100 mg/ …	Cohort 2: Placebo	Cohort 2: TAK-828 3 mg/ Fa…	Cohort 2: TAK-828 50 mg/ F…	Cohort 2: TAK-828 200 mg/ …	Cohort 2: TAK-828 100 mg/ …	Cohort 2: TAK-828 100 mg/ …	Cohort 3: Placebo	Cohort 3: TAK-828 15 mg/ F…	Cohort 3: TAK-828 100 mg/ …	Cohort 3: TAK-828 150 mg/ …
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal discomfort	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Fatigue	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Feeling abnormal	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Musculoskeletal discomfort	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Temporomandibular joint syndrome	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Presyncope	Nervous system disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Chromaturia	Renal and urinary disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Dermatitis contact	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Orthostatic hypotension	Vascular disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Foreign body reaction	General disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Arthropod bite	Injury, poisoning and procedural complications	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Sleep disorder	Psychiatric disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—
Hyperhidrosis	Skin and subcutaneous tissue disorders	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—	—

Most-reported serious reactions: Ventricular tachycardia.

Data from ClinicalTrials.gov NCT02706834 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and tolerability of single oral doses of TAK-828 in healthy non-Japanese and Japanese participants.

Publications & conference data

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

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NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02706834 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 19 October 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02706834.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02706834

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of TAK-828

Other Takeda trials

Verify against primary sources