Last updated on March 2019

A Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of TAK-925 in Healthy Volunteers and Patients With Narcolepsy

Brief description of study

The purpose of this study is to investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TAK-925 when administered to healthy participants and narcolepsy patients.

Detailed Study Description

The drug being tested in this study is called TAK-925. TAK-925 is being tested in healthy participants and patients with narcolepsy. This study will look at the safety, tolerability, pharmacokinetics, and efficacy of TAK-925.

This study will consist of three parts. Part A will be a randomized, double-blind, placebo-controlled, multiple rising dose (MRD) study in healthy participants. Part B is a randomized, double-blind, placebo-controlled MRD study in patients with narcolepsy. Part C is a randomized, double-blind, placebo-controlled, parallel group, multiple repeat dose study in patients with narcolepsy.

The study will enroll approximately 84 participants planned as total. All participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groupswhich will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

Part A study;

  • TAK-925 (Dose Levels A1-A6)
  • Placebo Part B study;
  • TAK-925 (Dose Levels B1-B4)
  • Placebo Part C study;
  • TAK-925 (Dose Levels C1-C2)
  • Placebo

All participants will be asked to take TAK-925 or Placebo at the same time each day from Day 1 to Day 7.

This multi-center trial will be conducted in Japan. The overall study period is 15 days. Participants will be partly admitted to a hospital during the study.

Clinical Study Identifier: NCT03748979

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