NCT04645524

Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	AD182	Oral capsule administered before bed
DRUG	AD504	Oral capsule administered before bed
DRUG	Placebo	Oral capsule administered before bed
DIAGNOSTIC_TEST	Polysomnography	for all arms

Timeline

• Start date: 2020-12-01
• Primary completion: 2021-09-01
• Completion: 2021-09-01
• First posted: 2020-11-27
• Last updated: 2022-09-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study