Phase 1
Completed N=40
Phase 1 Study of TAK-831 in Healthy Adult Asian Subjects
Healthy Volunteers
Source: ClinicalTrials.gov NCT03687684 ↗
Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcomePrimary: Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) — 0; 2; 0; 4 Participants
Summary
The purpose of this study is to evaluate safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-831 when administered as single or multiple oral doses in healthy adult Asian participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reporting at Least One Treatment-emergent Adverse Event (TEAE) |
0; 2; 0; 4; 4; 1 | — |
| PRIMARY Number of Participants Reporting at Least One TEAE Related to Laboratory Test Results |
0; 2; 0; 2; 2; 1 | — |
| PRIMARY Number of Participants Reporting at Least One TEAE Related to Vital Sign |
0; 0; 0; 1; 1; 0 | — |
| PRIMARY Number of Participants Reporting at Least One TEAE Related to Body Weight |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Number of Participants Reporting at Least One TEAE Related to 12-lead Electrocardiogram (ECG) Parameters |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Cmax: Maximum Observed Plasma Concentration for TAK-831 |
985.5; 1823; 981.7; 1602; 339.9; 1807 | — |
| SECONDARY Cohorts 2 to 5, Cmax, ss: Maximum Observed Steady-state Plasma Concentration During a Dosing Interval for TAK-831 |
831.8; 1903; 417.0; 1581 | — |
| SECONDARY Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-831 |
0.5000; 0.5000; 2.000; 1.750; 0.5000; 1.500 | — |
| SECONDARY AUClast: Area Under the Plasma Concentration-time Curve (AUC) From Time 0 to Time of the Last Quantifiable Concentration for TAK-831 |
1553; 3630; 3700; 6477; 847.4; 5504 | — |
| SECONDARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 |
1581; 3653; 3730; 6518; 923.6; 5530 | — |
| SECONDARY Cohorts 2 to 5, AUCtau: Area Under the Plasma Concentration-time Curve From Time 0 to [Time] Over the Dosing Interval for TAK-831 |
3576; 6211; 794.5; 5340; 2738; 8237 | — |
Eligibility Criteria
Inclusion Criteria
- The participant must understand the study procedures and agree to participate by providing written informed consent (for Chinese participants, an interpreter should be present as necessary).
- The participant must be willing and able to comply with all study procedures and restrictions.
- The participant must be male or female (of nonchildbearing potential) aged 20 to 55 years, inclusive, at the Screening.
- The participant must have a body mass index (BMI) >=18.5 kg/m^2 and = 450 milliseconds (msec) (males) or >470 msec (females) or PR outside the range of 120 to 220 msec at the Screening Visit or Check-in.
Data sourced from ClinicalTrials.gov (NCT03687684). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.