AD109 Dose Finding in Mild to Moderate OSA

NCT04631107 | Completed Phase 2 Results FDA Drug

• 1 other identifier: APC-004
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief Summary

This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild obstructive sleep apnea.

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (2)

• Change in Hypoxic Burden (HB) Log Transformed - Log10HB[(%*Min)/h]

  Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/h\]. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.

  1 night (8 hours)

• Change in Hypoxic Burden (HB) Raw Values - HB[(%*Min)/h]

  Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Raw measurement of HB (%min/h) is defined as the sum of individual areas (%min) divided by total sleep time (h). Events with 4% or greater desaturations were included in the calculation of HB.

  1 night (8 hours)

Study Arms (6)

Sequence ABC

OTHER

AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B), then Placebo (C).

Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Sequence ACB

OTHER

AD109 Dose 1- 75 mg (A), then Placebo (C) then AD109 Dose 2- 37.5 mg (B)

Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Sequence BAC

OTHER

AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A), then Placebo (C)

Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Sequence BCA

OTHER

AD109 Dose 2- 37.5 mg (B), then Placebo (C), then AD109 Dose 1- 75 mg (A)

Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Sequence CAB

OTHER

Placebo (C), then AD109 Dose 1- 75 mg (A), then AD109 Dose 2- 37.5 mg (B)

Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Sequence CBA

OTHER

Placebo (C), then AD109 Dose 2- 37.5 mg (B), then AD109 Dose 1- 75 mg (A)

Drug: AD109 dose1- A; Drug: AD109 dose2- B; Drug: Placebo- C

Interventions

AD109 dose1- A DRUG

Oral administration at bedtime

Also known as: AD109 75

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

AD109 dose2- B DRUG

Oral administration at bedtime

Also known as: AD109 37.5

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Placebo- C DRUG

Oral administration at bedtime

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• AHI between 5 and 20 events/h
• PGI-S equal to or higher than 1, or one or more of the following symptoms:
• Snoring or nightime gasping/choking
• Daytime sleepiness, fatigue or decreased concentration
• Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
• Irritability, decreased mood or libido

You may not qualify if:

• History of narcolepsy.
• 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).
• CPAP should not be used for at least 2 weeks prior to the study
• 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.

Sponsors & Collaborators

• Apnimed: lead

Study Sites (3)

Pacific Research Network

San Diego, California, 92103, United States

Location

NeuroTrial Research

Atlanta, Georgia, 30328, United States

Location

Brian Abaluck, LLC

Philadelphia, Pennsylvania, 19063, United States

Location

Related Publications (1)

• Rosenberg R, Abaluck B, Thein S. Combination of atomoxetine with the novel antimuscarinic aroxybutynin improves mild to moderate OSA. J Clin Sleep Med. 2022 Dec 1;18(12):2837-2844. doi: 10.5664/jcsm.10250.

  PMID: 35975547 RESULT

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Results Point of Contact

• Title: Clinical Trials
• Organization: Apnimed, Inc.

clinicaltrials@apnimed.com

617-500-8880

Study Officials

• Ron Farkas, MD

  Apnimed

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 17, 2020
• Study Start: December 22, 2020
• Primary Completion: May 31, 2021
• Study Completion: May 31, 2021
• Last Updated: December 22, 2022
• Results First Posted: December 22, 2022

Record last verified: 2022-11

Locations

US (3)