NCT03224325

A Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Participants

A Randomized, Investigator and Subject Blinded, Sponsor Unblinded Placebo-Controlled Phase I Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Escalating Multiple Doses of TAK-831 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Neurocrine Biosciences · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of TAK-831 when administered as multiple oral doses at escalating dose levels in healthy participants.

Detailed description

This study is a randomized, investigator and participant blinded, sponsor unblinded, placebo-controlled, study of the safety, tolerability and pharmacokinetics of TAK-831 in up to 48 healthy volunteers, with 8 subjects in each of the 6 cohorts. In each cohort, participants will be randomized in a 3:1 ratio to receive TAK-831 or placebo. Two formulations, oral suspension and tablet will be tested in this study. Both blood and cerebrospinal fluid (CSF) samples will be collected from selected cohorts (CSF cohorts); for the rest of the cohorts, only blood samples will be collected (non-CSF cohorts). This single-center trial will be conducted in the United States. The overall time to participate in this study is 58 days. Participants will make multiple visits to the clinic, and 30 days after last dose of study drug for a follow-up assessment.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	TAK-831 Tablet T2	Tak-831 tablets.
DRUG	Placebo	TAK-831 placebo-matching suspension.
DRUG	TAK-831 Suspension	TAK-831 Suspension.

Timeline

• Start date: 2017-07-21
• Primary completion: 2018-09-09
• Completion: 2018-09-09
• First posted: 2017-07-21
• Last updated: 2021-06-14
• Results posted: 2019-11-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study