Last updated on June 2020

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

Brief description of study

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

Detailed Study 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 infusion.

The multicenter study will be conducted in US and Japan. The overall duration of treatment in this study is approximately 43 days including up to 28 day screening period and a follow up safety visit 7 days post last dose for all.

Clinical Study Identifier: NCT04091438

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Preferred Research Partners, Inc.

Little Rock, AR United States
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Recruitment Status: Open

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