AD816 Crossover Study

Completed · Phase 2 · Has a placebo group

Conditions studied: OSA, Obstructive Sleep Apnea

In brief

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

Key facts

Study ID

NCT05793684

Run by

Apnimed

People needed

25

Starts

2023-04-28

Expected to finish

2023-11-09

Last updated by the study team

2023-11-15

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

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.
• Women who are pregnant or nursing.
• CPAP should not be used for at least 2 weeks prior to first study PSG and during entire participation in the study.
• History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used for at least 2 weeks prior to first study PSG and during participation in the study.
• History of using devices to affect participant sleeping position for the treatment of OSA, e.g. to discourage supine sleeping position, may enroll as long as the devices are not used for at least 2 weeks prior to first study PSG and during participation in the study.
• Chronic oxygen therapy.
• Patients with hypoglossal nerve stimulation implant. Prior/Concurrent Clinical Study Experience
• Use of another investigational agent within 30 days or 5 half-lives, whichever is longer, prior to dosing.
• Prolonged QT interval (> 450 ms in men or > 470 ms in women, after correction with most appropriate formula for observed heart rate), hypokalemia or hypomagnesemia (defined as >0.1 mEq/L below lower limit of normal for the testing laboratory).
• Hepatic transaminases >2X the upper limit of normal (ULN), total bilirubin >1.5X ULN (unless confirmed Gilbert syndrome), estimated glomerular filtration rate < 50 ml/min.
• Night- or shift-work sleep schedule which causes the major sleep period to be during the day, or planned travel across more than 1 time zone during the anticipated enrollment period

Where it is running

• Santa Monica Clinical Trials — Los Angeles, California, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Clayton Sleep Institute — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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