NCT03522506

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of TAK-925 Study in Sleep-Deprived Healthy Adults

A Phase 1b, 4-Period Crossover, Placebo-Controlled, Randomized, Single Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TAK-925 in Sleep-Deprived Healthy Adults Utilizing Modafinil as an Active Comparator

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Takeda · Industry
• Sex: Male
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to determine the effect of TAK-925 after a single intravenous dose (compared to placebo) on promoting wakefulness as measured by sleep latency on the maintenance of wakefulness (MWT) in sleep-deprived healthy participants.

Detailed description

The drug being tested in this study is called TAK-925. This study will assess the safety, tolerability, PK and PD of TAK-925 and will assess the effects of TAK-925 in sleep-deprived healthy adult participants. The study will enroll approximately 20 participants. Participants will be randomly assigned (by chance, like flipping a coin) to one of the 4 treatment sequences-which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK-925 Low Dose + Placebo + TAK-925 High Dose + Modafinil * TAK-925 High Dose + TAK-925 Low Dose + Modafinil + Placebo * Modafinil+ TAK-925 High Dose + Placebo + TAK-925 Low Dose * Placebo + Modafinil + TAK-925 Low Dose + TAK-925 High Dose TAK-925 will be administered as an intravenous infusion based on the availability of safety, tolerability and PK data from health Japanese participants in ongoing study TAK-925-1001. 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 make a final visit 7 days after receiving their last dose of drug for a follow-up assessment.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	TAK-925	TAK-925 intravenous infusion.
DRUG	TAK-925 Placebo	TAK-925 placebo-matching given as saline intravenous infusion.
DRUG	Modafinil	Modafinil tablets.
DRUG	Modafinil Placebo	Modafinil placebo-matching tablet.

Timeline

• Start date: 2018-05-09
• Primary completion: 2018-11-07
• Completion: 2018-11-07
• First posted: 2018-05-11
• Last updated: 2021-03-26
• Results posted: 2019-11-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study