Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

Phase 2

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Drug: AD182; Drug: Placebo; Drug: AD504; Diagnostic Test: Polysomnography

• Registration Number: NCT04645524
• Lead Sponsor: Apnimed

Brief Summary

This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

Detailed Description

The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.

Study Timeline

• Study First Submitted: 2020-11-21
• Study First Submitted QC: 2020-11-21
• Study First Posted: 2020-11-27
• Study Start: 2020-12-01
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Status Verified: 2022-08
• Disposition First Submitted: 2022-08-16
• Disposition First Submitted QC: 2022-08-16
• Disposition First Posted: 2022-08-18
• Last Update Submitted: 2022-08-31
• Last Update Posted: 2022-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit
• AHI 10 to 55 events/h if meets other PSG criteria

Exclusion Criteria

• History of narcolepsy.
• Clinically significant craniofacial malformation.
• Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
• CPAP should not be used for at least 2 weeks prior to first study PSG
• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AD182	AD182	Oral capsule administered before bed
AD182	Polysomnography	Oral capsule administered before bed
AD504	Polysomnography	Oral capsule administered before bed
Placebo	Placebo	Oral capsule administered before bed
Placebo	Polysomnography	Oral capsule administered before bed
AD504	AD504	Oral capsule administered before bed

Primary Outcome Measures

Name	Time	Method
Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)	1 night (treatment duration)	Apnea-Hypopnea Index, AD182 and AD504 vs placebo

Trial Locations

Locations (1)

Intrepid research, LLC; 🇺🇸 Cincinnati, Ohio, United States