AD816 Crossover Study

NCT05793684 | Completed Phase 2 FDA Drug

• 1 other identifier: APV-001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 3

Brief Summary

The VicTor Study is a randomized, double blind, placebo-controlled, 3-period, multiple-dose crossover study in participants with OSA.

Conditions

OSA; Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo

  Apnea-hypopnea index based on 4% hypopnea desaturation

  14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)

Study Arms (6)

Order: Period A, Period B, Period C

EXPERIMENTAL

The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Drug: Period A; Drug: Period B; Drug: Period C

Order: Period B, Period C, Period A

EXPERIMENTAL

The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Drug: Period A; Drug: Period B; Drug: Period C

Order: Period C, Period A, Period B

EXPERIMENTAL

The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Drug: Period A; Drug: Period B; Drug: Period C

Order: Period A, Period C, Period B

EXPERIMENTAL

The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Drug: Period A; Drug: Period B; Drug: Period C

Order: Period B, Period A, Period C

EXPERIMENTAL

The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Drug: Period A; Drug: Period B; Drug: Period C

Order: Period C, Period B, Period A

EXPERIMENTAL

The sequence of periods for each participant are assigned in random order. Each of the three crossover periods is 14 days of uninterrupted nightly dosing, with an initial lower-dose week of investigational product (IP) followed by a higher dose week (or placebo each week).

Drug: Period A; Drug: Period B; Drug: Period C

Interventions

Period A DRUG

Week 1: Viloxazine low dose + placebo; Week 2: Viloxazine high dose + placebo

Order: Period A, Period B, Period C; Order: Period A, Period C, Period B; Order: Period B, Period A, Period C; Order: Period B, Period C, Period A; Order: Period C, Period A, Period B; Order: Period C, Period B, Period A

Period B DRUG

Week 1: AD816 low dose; Week 2: AD816 high dose

Order: Period A, Period B, Period C; Order: Period A, Period C, Period B; Order: Period B, Period A, Period C; Order: Period B, Period C, Period A; Order: Period C, Period A, Period B; Order: Period C, Period B, Period A

Period C DRUG

Week 1: Placebo + Placebo; Week 2: Placebo + Placebo

Order: Period A, Period B, Period C; Order: Period A, Period C, Period B; Order: Period B, Period A, Period C; Order: Period B, Period C, Period A; Order: Period C, Period A, Period B; Order: Period C, Period B, Period A

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Between 18 to 75 years of age, inclusive, at the Screening Visit
• PSG criteria (V2 only)
• AHI4 (Hypopneas defined by 4% oxygen desaturation) of 10-45, inclusive
• ≤25% of events are central or mixed apneas
• PROMIS Fatigue or sleep related impairment or sleep disturbance (raw score): \>11, i.e. at least "very mild symptoms" at V1
• BMI between 18.5 and 40 kg/m2, inclusive
• Male participants:
• If sexually active with female partner(s) of childbearing potential, participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception
• Female participants:
• If of childbearing potential (WOCBP), the participant must agree, from Study Day 1 through 1 week after the last dose of study drug, to practice the protocol specified contraception. All WOCBP must have negative result of a serum pregnancy test performed at screening.
• a. Females of non-childbearing potential include postmenopausal (defined as age ≥ 55 years with no menses for 12 or more months without an alternative medical cause) or permanently sterile (e.g. bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
• Participant voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB)-approved informed consent prior to performing any of the Screening Visit procedures.
• Participant must be able to understand the nature of the study and must have the opportunity to have any questions answered

You may not qualify if:

• Current clinically significant sleep disorder other than OSA of a severity that would interfere with study participation or interpretability of data.
• Clinically significant craniofacial malformation or grade ≥3 tonsillar hypertrophy.
• Current clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or poorly controlled hypertension (\>140/90mmHg).
• Long QT syndrome or family history of long QT syndrome
• Current clinically significant neurological disorder, including epilepsy/convulsions.
• Other active major organ system disease including renal failure, lung disease, neuromuscular disease, or liver disease.
• Schizophrenia, schizoaffective disorder or bipolar disorder according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) or International Classification of Disease tenth edition criteria.
• Attempted suicide within 1 year prior to screening, or current suicidal ideation.
• Clinically significant urinary retention, gastric retention or other severe decreased gastrointestinal motility condition.
• Benign prostatic hypertrophy that is actively being treated with alpha-1 adrenergic antagonist
• Severe or frequent gastroesophageal reflux or constipation
• Medically unexplained positive screen for drugs of abuse (excluding THC/marijuana) or history of substance use disorder as defined in DSM-V within 24 months prior to Screening Visit.
• A serious illness or infection in the past 30 days as determined by investigator.
• Clinically significant cognitive dysfunction as determined by investigator.
• Untreated narrow angle glaucoma.

Sponsors & Collaborators

• Apnimed: lead

Study Sites (3)

Santa Monica Clinical Trials

Los Angeles, California, 90025, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Clayton Sleep Institute

St Louis, Missouri, 63143, United States

Location

Related Publications (1)

• Aishah A, Kim M, Gell L, Vena D, Azarbarzin A, Pho H, Norman D, Ojile J, Esmaeili N, Taranto-Montemurro L, Wellman A, Sands S, Messineo L. Effect of viloxazine and trazodone in obstructive sleep apnoea: a randomised, placebo-controlled, cross-over study. Thorax. 2025 Aug 15;80(9):641-649. doi: 10.1136/thorax-2024-222513.

  PMID: 40360261 DERIVED

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

Study Officials

• Ronald Farkas, MD

  Apnimed Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind study
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2023
• First Posted: March 31, 2023
• Study Start: April 28, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)