NCT04091438

A Study of a Single Intravenous Infusion Dose of TAK-925 in Participants With Idiopathic Hypersomnia

A Phase 1b Randomized, Double-Blind, Placebo-Controlled, Crossover Study of a Single Intravenous Infusion Dose of TAK-925 in Patients With Idiopathic Hypersomnia

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Millennium Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and tolerability of administering a single intravenous (IV) infusion dose of TAK-925 to adult participants with idiopathic hypersomnia (IH).

Detailed description

The drug being tested in this study in participants with IH is called TAK-925. The study will have 2-treatment crossover groups. The study will evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of a single intravenous (IV) dose of Dose A in participants with IH. The study will enroll 40 patients. Participants will be randomly assigned to one of the two treatment sequence groups as indicated below: * TAK-925 + Placebo * Placebo + TAK-925 On Day 1 of each treatment period, TAK-925 or placebo will be administered as a single 9-hour IV infusion. The multicenter study will be conducted in the United States and Japan. The overall duration of treatment in this study is approximately 41 days including screening up to 28 days, confinement for 6 days and end of study follow up telephone call on Study Day 11.

Conditions

• Idiopathic Hypersomnia

Interventions

Type	Name	Description
DRUG	TAK-925	TAK-925 IV infusion.
DRUG	TAK-925 Placebo	TAK-925 placebo-matching IV infusion.

Timeline

• Start date: 2020-01-26
• Primary completion: 2020-11-19
• Completion: 2020-11-23
• First posted: 2019-09-16
• Last updated: 2023-09-26
• Results posted: 2023-09-26

Locations

22 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study