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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03101293
• Other study ID #: TAK-831-1004
• Secondary ID: U1111-1189-8001
• Status: Completed
• Phase: Phase 1
• Start date: April 4, 2017
• Est. completion date: May 26, 2017

Study information

• Verified date: June 2021
• Source: Neurocrine Biosciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: May 26, 2017
• Est. primary completion date: May 19, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. 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:

1. Has received TAK-831 in a previous clinical study.

2. Has poor peripheral venous access.

3. 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.

4. Has any dietary restrictions or preferences that may interfere with the conduct of the study.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• TAK-831
TAK-831 film-coated tablet.

Locations

Country	Name	City	State
United States	PRA Health Sciences	Lenexa	Kansas

Sponsors (2)

Lead Sponsor	Collaborator
Neurocrine Biosciences	Takeda

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax: Maximum Observed Plasma Concentration for TAK-831		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Primary	AUClast: Area Under the Plasma Concentration-time Curve From Time 0 to the Time of the Last Quantifiable Concentration for TAK-831		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Primary	AUC8: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-831		Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose
Secondary	Percentage of Participants Who Experience at Least 1 Treatment-emergent Adverse Event (TEAE)		Day 1