Phase 1
Completed N=15
A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation
Healthy Volunteers
Source: ClinicalTrials.gov NCT03101293 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Mar 2019
Primary outcomePrimary: Cmax: Maximum Observed Plasma Concentration for TAK-831 — 650.04; 865.48 nanogram per milliliter (ng/mL) — p=0.0058
Summary
The purpose of this study is to determine the pharmacokinetic (PK) of a single oral dose of TAK-831 400 milligram (mg) in the fasted state and to estimate the effect of food on the PK of a single oral dose of TAK-831 400 mg when administered as tablet formulation in healthy participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-831 |
650.04; 865.48 | 0.0058 sig |
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 |
2290.8; 2535.6 | 0.1763 |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 |
2194.8; 2465.9 | 0.2745 |
| SECONDARY Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE) |
0; 7.1 | — |
Eligibility Criteria
Inclusion Criteria
- Weighs greater than or equal to (>=) 45 kilogram (kg) and has a body mass index (BMI) between 18.0 and 30.0 kilogram per square meter (kg/m^2), inclusive at Screening.
Exclusion Criteria
- Has received TAK-831 in a previous clinical study.
- Has poor peripheral venous access.
- Has donated or lost 450 milliliter (mL) or more of his or her blood volume (including plasmapheresis), or had a transfusion of any blood product within 45 days prior to first dose of study drug.
- Has any dietary restrictions or preferences that may interfere with the conduct of the study.
Data sourced from ClinicalTrials.gov (NCT03101293). 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.