Phase 1
Completed N=16
A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants
Healthy Volunteers
Source: ClinicalTrials.gov NCT03706469 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcomePrimary: AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 — 714.8; 597.5; 4563; 4665 nanogram*hour per milliliter(ng*hr/mL)
Summary
The purpose of this study is to assess the oral BA of TAK-831 T3 tablet formulation relative to TAK-831 T2 tablet formulation under fasting conditions and to assess the effect of food on the pharmacokinetics (PK) of TAK-831 T3 tablet formulation.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831 |
714.8; 597.5; 4563; 4665; 8058 | — |
| PRIMARY AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831 |
761.8; 688.6; 4665; 4558; 7934 | — |
| PRIMARY Cmax: Maximum Observed Plasma Concentration for TAK-831 |
397.5; 314.6; 1384; 1381; 2394 | — |
| SECONDARY Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE) |
0; 13; 0; 6; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) greater than or equal to (>=) 18.0 and less than (<) 30.0 kilogram per square meter (kg/m^2), at Screening.
Exclusion Criteria
- History or presence of alcoholism or drug abuse within the past 2 years prior to the first dosing.
- Smokes more than 20 cigarettes or equivalent per day within 3 months prior to the first dose and is unwilling to discontinue use of any tobacco- or nicotine-containing products during the confinement period(s) of the study.
- Has been on a diet incompatible with the on-study diet, in the opinion of the Investigator or designee, within the 30 days prior to the first dosing and throughout the study.
- Is lactose intolerant or unable/unwilling to eat the high-fat breakfast.
- Donation of blood or significant blood loss within 56 days prior to the first dosing.
Data sourced from ClinicalTrials.gov (NCT03706469). 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.