NCT03933488

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Participants

A Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Rising Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-994 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 121 (actual)
• Sponsor: Takeda · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of TAK-994 following single and multiple oral doses in healthy non-Japanese and Japanese adult participants and healthy elderly participants.

Detailed description

The drug being tested in this study is called TAK-994. TAK-994 is being tested to find a safe and well-tolerated dose in healthy participants (non-Japanese and Japanese) and healthy elderly participants. The study will enroll up to approximately 160 healthy participants. The study consists of 6 parts and up to 20 cohorts as mentioned below. * TAK-994: Part A: Single-rising dose (SRD) design to assess the safety, tolerability, and PK of TAK-994 and effect of food on the PK of the TAK-994 * TAK-994: Part B: MRD design to assess the safety, tolerability, PK and PD of TAK-994 * TAK-994: Part C: MRD design to assess the safety, tolerability, PK and PD of TAK-994 and also central nervous system penetration relative to plasma concentrations of TAK-994 * TAK-994: Part D: MRD design to assess the safety, tolerability, PK and PD of TAK-994 for HE participants * TAK-994: Part E: SRD and MRD design to assess the safety, tolerability, PK and PD of TAK-994 for Japanese origin participants * TAK-994: Part F (Optional Cohort): Nonrandomized design to assess orexin (OX) levels in the cerebrospinal fluid (CSF) of untreated healthy adult participants. Participants in each cohort will be randomized to receive treatment with TAK-994 or matching placebo which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need). Participants in optional Part F will receive no study drug. This multi-center trial will be conducted in the United States. The overall duration of the study is approximately 10 months. Participants will be followed up for 7 days after the last dose of study drug for a follow-up assessment.

Conditions

• Healthy Participants

Interventions

Type	Name	Description
DRUG	TAK-994	TAK-994 tablets.
DRUG	TAK-994 Placebo	TAK-994 placebo-matching tablets.

Timeline

• Start date: 2019-05-01
• Primary completion: 2020-03-29
• Completion: 2020-03-29
• First posted: 2019-05-01
• Last updated: 2020-06-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study