NCT04551079

A Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics (PK) of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Participants

A Randomized, Double-Blind, Placebo-Controlled, 3-Period Crossover Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Oral TAK-994 in an Acute Sleep Phase Delay Paradigm in Healthy Male Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety and tolerability of TAK-994 and to determine the effect of TAK-994 (compared to placebo) on sleepiness, as measured by mean sleep latency on the maintenance of wakefulness Test (MWT), in an acute sleep phase delay paradigm in healthy participants.

Detailed description

The drug being tested in this study is called TAK-994. The study will evaluate the safety/tolerability, PD, and PK of TAK-994 in an acute sleep phase delay paradigm in healthy participants. The study will enroll up to approximately 18 healthy participants. Participants will be randomly assigned to 1 of the 3 treatment sequences which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK-994 Dose A + Placebo + TAK-994 Dose B * TAK-994 Dose B + TAK-994 Dose A + Placebo * Placebo + TAK-994 Dose B + TAK-994 Dose A This single center trial will be conducted in the United States. The overall time to participate in this study is approximately 10 weeks. Participants will be followed up remotely on Day 7 after the last dose of study drug for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

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

Timeline

• Start date: 2020-09-23
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2020-09-16
• Last updated: 2021-01-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study