Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Study Overview
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Brief Summary
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This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

Official Title
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Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea

Conditions
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OSA - Obstructive Sleep Apnea

Intervention / Treatment
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* Drug: AD109
* Drug: AD504
* Drug: Atomoxetine Hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit. Mean AHI 10 to 45 events/h, inclusive PGI-S: >1 Exclusion Criteria: Current clinically significant sleep disorder other than OSA Clinically significant craniofacial malformation. Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control). Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD109 Dose 1<br> | Drug: AD109<br>* Oral administration at bedtime<br>|
| Experimental: AD109 Dose 2<br> | Drug: AD109<br>* Oral administration at bedtime<br>|
| Experimental: AD504 Dose 1<br> | Drug: AD504<br>* Oral administration at bedtime<br>|
| Experimental: AD504 Dose 2<br> | Drug: AD504<br>* Oral administration at bedtime<br>|
| Active Comparator: Atomoxetine 1<br> | Drug: Atomoxetine Hydrochloride<br>* Oral administration at bedtime<br>|
| Active Comparator: Atomoxetine 2<br> | Drug: Atomoxetine Hydrochloride<br>* Oral administration at bedtime<br>|
| Placebo Comparator: Placebo 1<br> | Drug: Placebo<br>* Oral administration at bedtime<br>|
| Placebo Comparator: Placebo 2<br> | Drug: Placebo<br>* Oral administration at bedtime<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHI, combined AD109 dose arms vs. combined placebo arms | Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography | 28 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in AHI, combined AD504 dose arms vs. combined placebo arms | Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography | 28 Days | 
| Change in AHI, combined atomoxetine dose arms vs. combined placebo arms | Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography | 28 Days |