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AD816 Crossover Study (VicTor)

Primary Purpose

OSA, Obstructive Sleep Apnea

Status
Active
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Period A
Period B
Period C
Sponsored by
Apnimed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for OSA

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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 Employment as a commercial driver or operator of hazardous equipment. Typically smoking more than 10 cigarettes or 2 cigars per day (or equivalent Vaping), or inability to abstain from smoking during overnight PSG visits. Unwilling to use specified contraception. History of regular alcohol consumption of more than 14 standard units per week (males) or more than 7 standard units per week (females), or unwillingness to limit alcohol consumption to no greater than 2 units/day (males), 1 unit per day (females). Alcohol is not to be consumed within 3 hours of bedtime or on PSG nights. Unwilling to agree to limit during the study period caffeinated beverage intake (e.g., coffee, cola, tea) to 200 mg/day or less of caffeine, not to be used within 3 hours of bedtime. Viloxazine may increase the duration of effect of caffeine. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. Participant considered by the investigator, for any reason, an unsuitable candidate to receive viloxazine or AD816 components, or unable or unlikely to understand or comply with the dosing schedule or study evaluations.

Sites / Locations

  • Santa Monica Clinical Trials
  • Brigham and Women's Hospital
  • Clayton Sleep Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Order: Period A, Period B, Period C

Order: Period B, Period C, Period A

Order: Period C, Period A, Period B

Order: Period A, Period C, Period B

Order: Period B, Period A, Period C

Order: Period C, Period B, Period A

Arm Description

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).

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).

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).

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).

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).

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).

Outcomes

Primary Outcome Measures

Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo
Apnea-hypopnea index based on 4% hypopnea desaturation

Secondary Outcome Measures

Full Information

First Posted
March 18, 2023
Last Updated
September 6, 2023
Sponsor
Apnimed
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1. Study Identification

Unique Protocol Identification Number
NCT05793684
Brief Title
AD816 Crossover Study
Acronym
VicTor
Official Title
Phase 2 Randomized Double-Blind Placebo-Controlled Multiple-Dose 3-Period Crossover Study to Compare a Fixed Dose Combination of AD816 to Viloxazine Alone and to Placebo in Obstructive Sleep Apnea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 28, 2023 (Actual)
Primary Completion Date
November 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Apnimed

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
OSA, Obstructive Sleep Apnea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Masking Description
Double-blind study
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Order: Period A, Period B, Period C
Arm Type
Experimental
Arm Description
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).
Arm Title
Order: Period B, Period C, Period A
Arm Type
Experimental
Arm Description
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).
Arm Title
Order: Period C, Period A, Period B
Arm Type
Experimental
Arm Description
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).
Arm Title
Order: Period A, Period C, Period B
Arm Type
Experimental
Arm Description
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).
Arm Title
Order: Period B, Period A, Period C
Arm Type
Experimental
Arm Description
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).
Arm Title
Order: Period C, Period B, Period A
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Period A
Intervention Description
Week 1: Viloxazine low dose + placebo; Week 2: Viloxazine high dose + placebo
Intervention Type
Drug
Intervention Name(s)
Period B
Intervention Description
Week 1: AD816 low dose; Week 2: AD816 high dose
Intervention Type
Drug
Intervention Name(s)
Period C
Intervention Description
Week 1: Placebo + Placebo; Week 2: Placebo + Placebo
Primary Outcome Measure Information:
Title
Apnea-hypopnea index (AHI) 4%, AD816 vs. Placebo
Description
Apnea-hypopnea index based on 4% hypopnea desaturation
Time Frame
14 days of treatment dosing per crossover arm (collected at the end of treatment dosing per crossover arm)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 Employment as a commercial driver or operator of hazardous equipment. Typically smoking more than 10 cigarettes or 2 cigars per day (or equivalent Vaping), or inability to abstain from smoking during overnight PSG visits. Unwilling to use specified contraception. History of regular alcohol consumption of more than 14 standard units per week (males) or more than 7 standard units per week (females), or unwillingness to limit alcohol consumption to no greater than 2 units/day (males), 1 unit per day (females). Alcohol is not to be consumed within 3 hours of bedtime or on PSG nights. Unwilling to agree to limit during the study period caffeinated beverage intake (e.g., coffee, cola, tea) to 200 mg/day or less of caffeine, not to be used within 3 hours of bedtime. Viloxazine may increase the duration of effect of caffeine. Any condition that in the investigator's opinion would present an unreasonable risk to the participant, or which would interfere with their participation in the study or confound study interpretation. Participant considered by the investigator, for any reason, an unsuitable candidate to receive viloxazine or AD816 components, or unable or unlikely to understand or comply with the dosing schedule or study evaluations.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald Farkas, MD
Organizational Affiliation
Apnimed Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Santa Monica Clinical Trials
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Clayton Sleep Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63143
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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AD816 Crossover Study

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