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

Idiopathic Hypersomnia Clinical Trial

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

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04091438
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 1
Start date January 26, 2020
Completion date November 23, 2020
View Details
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