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A Pharmacokinetic and Safety Study of TAK-925 in Participants With Idiopathic Hypersomnia

2019-09-20 03:46:40 | BioPortfolio

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 participants with idiopathic hypersomnia (IH).

Description

The drug being tested in this study is called TAK-925. TAK-925 is being tested to treat participants who have IH. 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.

- 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 multicentre study will be conducted in US and Japan. The overall duration of treatment in this study is approximately 39 days. Participants make multiple visits to the clinic and will be followed up 7 days after the end of treatment for safety follow-up.

Study Design

Conditions

Idiopathic Hypersomnia

Intervention

TAK-925, TAK-925 Placebo

Status

Not yet recruiting

Source

Takeda

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-09-20T03:46:40-0400

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