Clinical trial NCT03796026: A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea
Official title: A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, 2-period, Crossover, Sleep Laboratory Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Patients With Obstructive Sleep Apnea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Sleep Apnea, Obstructive
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2019-01-08
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the effect of multiple doses of seltorexant compared with placebo on respiration during sleep in adult participants with mild to moderate obstructive sleep apnea.


Eligibility criteria: Inclusion Criteria:

* Participant must be a women of non-childbearing potential (WONCBP) or man. A WONCBP is defined as: a) Postmenopausal (postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy; b) Permanently sterile (permanent sterilization methods include hysterectomy, bilateral salpingectomy, bilateral tubal occlusion/ligation procedures, and bilateral oophorectomy
* Meet the International Classification of Sleep Disorder diagnostic criteria for obstructive sleep apnea (OSA) based on the investigator's assessment with or without sleep study. The OSA diagnosis can be confirmed by previous sleep studies, appropriate documentations (for example, medical records or letters from treating physicians) or documented conversation with the treating physician
* Mild to moderate OSA, defined as AHI greater than or equal to (\>=)5 to less than (\<)30, based on screening polysomnography (PSG)
* Body mass index (BMI) between 18 and 40 kilogram per meter square (kg/m\^2) (inclusive) (BMI = weight/height\^2)
* Must be otherwise healthy based on physical examination, medical history, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests performed at screening. If there are abnormalities, they must be consistent with the underlying illness in the study population. If the results of the clinical laboratory tests are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities from normal to be not clinically significant or to be appropriate and reasonable for the population under study

Exclusion Criteria:

* Has a history of, or current signs and symptoms of, severe renal insufficiency (creatinine clearance \<30 milliliter per minute \[mL/min\]); moderate to severe hepatic insufficiency (Child-Pugh Score \>=7), significant or unstable cardiovascular, respiratory, gastrointestinal, neurologic, hematologic, rheumatologic, immunologic, or endocrine disorders (including uncontrolled hypo- or hyperthyroidism or diabetes mellitus). Participants with diabetes mellitus who are under good control (hemoglobin A1c \[HbA1c\] \<= 8.5 percent \[%\] and fasting glucose \<=140 milligram per deciliter \[mg/dL\] at screening) may be eligible to participate if otherwise medically healthy, and if on a stable regimen of glucose-lowering medications for at least 2 months prior to screening
* Screening PSG with oxygen (O2) saturation \<=80% for \>=5% of total sleep time (TST)
* Screening PSG with \>=10 periodic limb movements per hour associated with an arousal
* Currently using or used within 7 days of screening a continuous positive airway pressure (CPAP), a dental appliance, or home oxygen use for OSA, or required to use any of them for the duration of the study
* Has other respiratory disorders such as chronic obstructive pulmonary disease (COPD) or asthma that need systemic and/or inhaled steroids, bronchiectasis, or emphysema, documented by history or physical examination

Primary outcomes:
measure: Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG)
timeFrame: Day 4
Secondary outcomes:
measure: AHI Score as Measured by PSG
timeFrame: Day 1 (Night)
measure: Mean Oxygen Saturation (SpO2) During Total Sleep Time (TST)
timeFrame: Nights 1 and 4
measure: Mean SpO2 During Rapid Eye Movement (REM), Non-Rapid Eye Movement (NREM), and Awake Stages
timeFrame: Nights 1 and 4
measure: Percentage of Total Sleep Time with SpO2 less than 90 percent (%), 85%, and 80%
timeFrame: Nights 1 and 4
measure: Mean Latency to Persistent Sleep (LPS) as Assessed by PSG
timeFrame: Nights 1 and 4
measure: Wake After Sleep Onset (WASO) by PSG
timeFrame: Nights 1 and 4
measure: Sleep Efficiency (SE) by PSG
timeFrame: Days 1, 2, 3, and 4
measure: Total Sleep Time (TST)
timeFrame: Nights 1 and 4
measure: Rapid Eye Movement (REM) Sleep Latency
timeFrame: Nights 1 and 4
measure: Total Duration of Rapid Eye Movement (REM) Sleep
timeFrame: Nights 1 and 4
measure: NREM Sleep Latency
timeFrame: Nights 1 and 4
measure: Total Duration of NREM Sleep
timeFrame: Nights 1 and 4
measure: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
timeFrame: Baseline up to end of study (approximately up to 9 weeks)
measure: Percentage of Participants with all Serious Adverse Events (SAEs) and Events of Special Interest
timeFrame: Baseline up to end of study (approximately up to 9 weeks)
measure: Number of Participants with Clinically Significant Vital Signs Abnormalities
timeFrame: Baseline up to end of study (approximately up to 9 weeks)
measure: Number of Participants with Clinically Significant Physical Examination Abnormalities
timeFrame: Baseline up to end of study (approximately up to 9 weeks)
measure: Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities
timeFrame: Baseline up to end of study (approximately up to 9 weeks)
measure: Number of Participants with Clinically Significant Laboratory Abnormalities
timeFrame: Baseline up to end of study (approximately up to 9 weeks)
measure: Number of participants with suicidal ideation measured using Columbia Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline, Days 1, 2, 4, 5, and end of study (approximately 9 weeks)
measure: Bond-Lader Visual Analog Scales (B-L VAS) Score
timeFrame: Baseline, Day 2, and Day 5
measure: Next-Day Residual Effect Measured by the Karolinska Sleepiness Scale (KSS) Score
timeFrame: Baseline, Day 2, and Day 5
measure: Residual Effect on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)
timeFrame: Baseline and Day 5
measure: Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)
timeFrame: Baseline and Day 5
measure: Residual Effect on Cognitive Function Measured by Hopkins Verbal Learning Test-Revised (HVLT-R)
timeFrame: Baseline and Day 5
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: NeuroTrials Research, Inc.
state: Georgia
city: New York
country: United States
facility: Clinilabs
state: New York
city: Cincinnati
country: United States
facility: CTI Clinical Trial and Consulting Services
state: Ohio
city: Knoxville
country: United States
facility: AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company
state: Tennessee
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: