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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
28
TAK-925 IV infusion.
TAK-925 placebo-matching IV infusion.
Wright Clinical Research
Alabaster, Alabama, United States
Percentage of Participants Who Experienced at Least One Treatment-emergent Adverse Event (TEAE)
Time frame: Study Day 1 up to Study Day 11
Percentage of Participants With Markedly Abnormal Criteria for Clinical Safety Laboratory Tests
Time frame: Study Day 1 up to Study Day 11
Percentage of Participants With Markedly Abnormal Criteria for Vital Sign Measurements
Time frame: From Predose up to Study Day 4
Percentage of Participants With Markedly Abnormal Criteria for 12-lead Safety Electrocardiogram (ECG) Parameters
Time frame: Study Day 1 up to Study Day 4
Ceoi: Observed Plasma Concentration at the End of Infusion for TAK-925
Time frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
AUC∞: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-925
Time frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
AUC Last: Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration for TAK-925
Time frame: Treatment Periods 1 and 2: Study Day 1 pre-dose, at multiple time points (up to 9 hours) after start of infusion, and at multiple time points (up to 15 hours) after end of infusion
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