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

NCT03101293 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: TAK-831-1004U1111-1189-8001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (3)

• Cmax: Maximum Observed Plasma Concentration for TAK-831

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

• 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

• AUC∞: 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 Outcomes (1)

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

  Day 1

Study Arms (2)

TAK-831 400 mg Fasted + TAK-831 400 mg Fed

EXPERIMENTAL

TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 2.

Drug: TAK-831

TAK-831 400 mg Fed + TAK-831 400 mg Fasted

EXPERIMENTAL

TAK-831 400 mg, film-coated tablets, orally under fed state, once on Day 1 of Intervention Period 1, followed by 7 days washout period, further followed by TAK-831 400 mg, film-coated tablets, orally under fasted state, once on Day 1 of Intervention Period 2.

Drug: TAK-831

Interventions

TAK-831 DRUG

TAK-831 film-coated tablet.

TAK-831 400 mg Fasted + TAK-831 400 mg Fed; TAK-831 400 mg Fed + TAK-831 400 mg Fasted

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Neurocrine Biosciences: lead
• Takeda: collaborator

Study Sites (1)

PRA Health Sciences

Lenexa, Kansas, 66219, United States

Location

Results Point of Contact

• Title: Neurocrine Medical Information
• Organization: Neurocrine Biosciences

medinfo@neurocrine.com

877-641-3461

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2017
• First Posted: April 5, 2017
• Study Start: April 4, 2017
• Primary Completion: May 19, 2017
• Study Completion: May 26, 2017
• Last Updated: June 14, 2021
• Results First Posted: March 18, 2019

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)