Crossover Trial of AD036 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, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea.

Detailed Description
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The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight Home Sleep Apnea Testing (HSAT) with dosing of one of the following 3 treatments: AD036, Atomoxetine, or Placebo. Participants will return 1 week after their final crossover HSAT for an end of study (EOS) Visit.

Official Title
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Phase 2, Randomized, 3-Period, Placebo-Controlled Crossover Study to Evaluate the Efficacy and Safety in Obstructive Sleep Apnea of AD036 Versus Placebo or Atomoxetine

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: AD036
* Drug: Atomoxetine
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit. AHI 10 to <20, or AHI ≥20 if meets 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: AD036<br>AD036 oral capsule administered before sleep | Drug: AD036<br>* Oral administration before bed<br>|
| Active Comparator: Atomoxetine<br>Atomoxetine oral capsule administered before sleep | Drug: Atomoxetine<br>* Oral administration before bed<br>|
| Placebo Comparator: Placebo<br>Placebo oral capsule administered before sleep | Drug: Placebo<br>* Oral administration before bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index | Apnea-Hypopnea Index(Disease severity is often defined based on the number of apneas and hypopneas per hour during sleep), AD036 vs. placebo | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoxic Burden | Hypoxic burden (a way to measure oxygen desaturation) determined by measuring the respiratory event-associated area under the desaturation curve from pre-event baseline, AD036 vs. placebo. Hypoxic Burden was measured during polysomnography (type of sleep study), while the patient was asleep | 1 day | 
| ODI | Oxygen Desaturation Index, measured by pulse-oximetry, AD036 vs. placebo | 1 day |