Home / TAK-925-1020
TAK-925-1020
Completed

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

Clinicaltrials.gov
#NCT05180890

About this clinical trial

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.

AU
Interventional Phase 1 clinical trial.

At a glance

What medical conditions were being studied?

Sleep Apnea

What was the clinical trial testing?

Placebo, Danavorexton

How many participants were enrolled?

13

Were placebos part of the clinical trial?

Yes

When was the clinical trial conducted?

Mar 2022 - Nov 2022

How long was participation in the clinical trial?

Participants will be in the study for up to 65 days, including treatment and follow-up visits.

Key requirements

Sex

All

Age

18-75 years

Healthy volunteers?

No

Entry criteria

Both men and women can take part.
Must be between 18 and 67 years old.
Must have Obstructive Sleep Apnea.
Must be able to stop vitamins, supplements, or dietary products during the study.
Cannot be on obstructive sleep apnea stimulation therapy.
Cannot have a job that required nighttime shift work in the last 2 months.
Cannot have a history of epilepsy, seizures, or known heart condition.
Additional entry criteria will be discussed with the study doctor.

Locations