Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-01

Study Completion Date

2021-09-01

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.

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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.

Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AD182

Oral capsule administered before bed

Group Type EXPERIMENTAL

AD182

Intervention Type DRUG

Oral capsule administered before bed

Polysomnography

Intervention Type DIAGNOSTIC_TEST

for all arms

AD504

Oral capsule administered before bed

Group Type EXPERIMENTAL

AD504

Intervention Type DRUG

Oral capsule administered before bed

Polysomnography

Intervention Type DIAGNOSTIC_TEST

for all arms

Placebo

Oral capsule administered before bed

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Oral capsule administered before bed

Polysomnography

Intervention Type DIAGNOSTIC_TEST

for all arms

Interventions

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AD182

Oral capsule administered before bed

Intervention Type DRUG

AD504

Oral capsule administered before bed

Intervention Type DRUG

Placebo

Oral capsule administered before bed

Intervention Type DRUG

Polysomnography

for all arms

Intervention Type DIAGNOSTIC_TEST

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.

Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No