A Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 Tablet Formulation

Completed · Phase 1

Conditions studied: Healthy Volunteers

In brief

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.

Key facts

Study ID

NCT03101293

Run by

Neurocrine Biosciences

People needed

15

Starts

2017-04-04

Expected to finish

2017-05-26

Last updated by the study team

2021-06-14

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• PRA Health Sciences — Lenexa, Kansas, United States

Full record on ClinicalTrials.gov

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