drugset / Trial / NCT05180890

A Study of Danavorexton (TAK-925) in Adults With Obstructive Sleep Apnea

NCT05180890

Phase 1 Completed 13 enrolled Takeda
RandomizedCrossoverTriple-blindTreatment

Summary

The main aim of the study is to check the side effects from overnight treatment with danavorexton and assess the tolerability of varying doses of danavorexton administered intravenously. Before starting treatment with danavorexton, participants will keep a sleep diary and use an under-mattress sensor for at least 7 nights to check regular sleep habits. There will be 3 Treatment Period up to 14 days apart. In each Treatment Period, participants will receive an intravenous (through the vein) infusion of either danavorexton or a placebo starting in the evening and continuing over a 10-hour period. A placebo looks exactly like danavorexton but does not have any medicine in it. Participants will take part in a follow-up phone appointment about a week after the last Treatment Period.

Timeline

Start
2022-03-10
Primary completion
2022-11-23
Completion
2022-11-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Danavorexton Small molecule Intravenous