Skip to main content
OpenTrials
Completed

NCT Number: NCT03101293

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PRA Health Sciences

Lenexa, Kansas, 66219, United States

About this study

The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants under fasting and fed conditions in order to determine the effect of food on the PK of single oral dose of TAK-831 tablet formulation. The study will enroll approximately 16 participants. Participants will be randomly and equally assigned (by chance, like flipping a coin) to 1 of the 2 treatment sequences following as:

  • TAK-831 400 mg Fasted + TAK-831 400 mg Fed
  • TAK-831 400 mg Fed + TAK-831 400 mg Fasted All participants will be asked to take single oral dose of TAK-831 tablet at the same time on Day 1 of each Intervention Period. This single center trial will be conducted in the United States. The overall time to participate in this study is 23 days. Participants will visit the clinic on Day -1 and remained confined until Day 3 of Intervention Period 1 and 2. A washout period of minimum 7 days will be maintained between the doses in each Intervention Period. Participants will make 3 visits to the clinic on Days 4, 6 and 8 on each Intervention Period and will be contacted by telephone 14 days after the last dose of study drug (Day 23) for a follow-up assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

TAK-831

Drug

TAK-831 film-coated tablet.

Primary outcomes

  1. Cmax: Maximum Observed Plasma Concentration for TAK-831

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

  2. AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

  3. AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831

    Time frame: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Secondary outcomes

  1. Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)

    Time frame: Day 1

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Collaborators

  • Takeda

Registry information

Official study title

A Randomized, Open-Label, Single-Dose, 2-Period, Crossover Design, Phase 1 Study to Evaluate the Effect of Food on the Pharmacokinetics of TAK-831 T2 Tablet Formulation in Healthy Subjects

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Apr 5, 2017
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.