NCT05101122

Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)

Open-Label 4-Period Dose-Escalation Safety and Efficacy Study of AD313 in Participants With Obstructive Sleep Apnea

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 25 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.

Detailed description

The SEED study is an open-label, 4 consecutive period dose-escalation study of combinations of AD313 vs. atomoxetine alone in participants with moderate- to severe OSA. A screening polysomnogram (PSG) will be conducted to establish that each participant meets study enrollment criteria and to serve as baseline. Each participant will then receive escalating doses of AD313 with on-drug PSGs to be conducted on the final night of dosing.

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	Dosing 1: Atomoxetine	Oral administration at bedtime
DRUG	AD313	Escalating dose of AD313; Oral administration at bedtime

Timeline

• Start date: 2021-10-19
• Primary completion: 2022-04-18
• Completion: 2022-04-18
• First posted: 2021-11-01
• Last updated: 2023-04-07
• Results posted: 2023-04-07

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study