Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: AD182
* Drug: AD504
* Drug: Placebo
* Diagnostic Test: Polysomnography


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD182<br>Oral capsule administered before bed | Drug: AD182<br>* Oral capsule administered before bed<br>Diagnostic Test: Polysomnography<br>* for all arms<br>|
| Experimental: AD504<br>Oral capsule administered before bed | Drug: AD504<br>* Oral capsule administered before bed<br>Diagnostic Test: Polysomnography<br>* for all arms<br>|
| Placebo Comparator: Placebo<br>Oral capsule administered before bed | Drug: Placebo<br>* Oral capsule administered before bed<br>Diagnostic Test: Polysomnography<br>* for all arms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) | Apnea-Hypopnea Index, AD182 and AD504 vs placebo | 1 night (treatment duration) |