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Completed

NCT Number: NCT03706469

A Study to Evaluate the Relative Bioavailability (BA) and Effect of Food on TAK-831 Tablet Formulations in Healthy Participants

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.

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Key information

Conditions

Healthy Volunteers

Age range

19 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

About this study

The drug being tested in this study is called TAK-831. TAK-831 is being tested in healthy participants to evaluate the relative BA and effect of food on the PK of TAK-831 tablet formulation.

The study will enroll approximately 16 participants. Participants will be randomly assigned (by chance, like flipping a coin) to TAK-831 in 1 of the 4 treatment sequences as following:

  • T2 50 mg Fasted + T3 50 mg Fasted + T3 600 mg Fasted + T2 600 mg Fasted + T3 600 mg Fed
  • T3 50 mg Fasted + T2 600 mg Fasted + T2 50 mg Fasted + T3 600 mg Fasted + T3 600 mg Fed
  • T2 600 mg Fasted + T3 600 mg Fasted + T3 50 mg Fasted + T2 50 mg Fasted + T3 600 mg Fed
  • T3 600 mg Fasted + T2 50 mg Fasted + T2 600 mg Fasted + T3 50 mg Fasted + T3 600 mg Fed

All participants will be asked to take tablet of assigned TAK-831 on Day 1 of each treatment period.

This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 70 days. Participants will make multiple visits to the clinic and will be contacted by clinic approximately 14 days after the last dose of study drug 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

  • 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.

Treatment and study plan

TAK-831 T2

Drug

TAK-831 T2 Tablets.

TAK-831 T3

Drug

TAK-831 T3 Tablets.

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. Percentage of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

    Time frame: Day 1 post dose up to 14 days after the last dose of study drug (Up to Day 47)

Sponsors and collaborators

Lead sponsor

Neurocrine Biosciences

Industry

Collaborators

  • Takeda

Registry information

Official study title

A Phase 1, Open-Label, Randomized, Single Dose, 5-Period, 5-Treatment Study to Evaluate the Relative Bioavailability and Effect of Food on TAK-831 Tablet Formulations in Healthy Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Oct 16, 2018
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.

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