NCT03796026CompletedPhase 1
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
Janssen Research & Development, LLC4 sites in 1 country34 target enrollmentStarted: January 4, 2019Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 34
- Locations
- 4
- Primary Endpoint
- Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Seltorexant Followed by Placebo
Experimental
Participants will receive seltorexant (40 milligram [mg] capsules) once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive matching placebo orally once daily for 4 consecutive days.
Intervention: Seltorexant 40 mg (Drug)
Seltorexant Followed by Placebo
Experimental
Participants will receive seltorexant (40 milligram [mg] capsules) once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive matching placebo orally once daily for 4 consecutive days.
Intervention: Placebo (Drug)
Placebo Followed by Seltorexant
Experimental
Participants will receive placebo once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive seltorexant (40 mg capsules) orally once daily for 4 consecutive days.
Intervention: Seltorexant 40 mg (Drug)
Placebo Followed by Seltorexant
Experimental
Participants will receive placebo once daily for 4 consecutive days, and after a washout period of 7 to 10 days, participants will receive seltorexant (40 mg capsules) orally once daily for 4 consecutive days.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG)
Time Frame: Day 4
AHI score is used to indicate the severity of sleep apnea. The AHI is calculated by dividing the number of apnea events by the number of hours of sleep. The AHI values for adults are categorized as: Normal: AHI less than (\<)5, Mild sleep apnea: 5 less than or equal to (\<=) AHI \<15, Moderate sleep apnea: 15\<= AHI \<30, and Severe sleep apnea: AHI greater than or equal to (\>=)30.
Secondary Outcomes
- Mean Latency to Persistent Sleep (LPS) as Assessed by PSG(Nights 1 and 4)
- Mean SpO2 During Rapid Eye Movement (REM), Non-Rapid Eye Movement (NREM), and Awake Stages(Nights 1 and 4)
- NREM Sleep Latency(Nights 1 and 4)
- Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability(Baseline up to end of study (approximately up to 9 weeks))
- AHI Score as Measured by PSG(Day 1 (Night))
- Mean Oxygen Saturation (SpO2) During Total Sleep Time (TST)(Nights 1 and 4)
- Percentage of Total Sleep Time with SpO2 less than 90 percent (%), 85%, and 80%(Nights 1 and 4)
- Sleep Efficiency (SE) by PSG(Days 1, 2, 3, and 4)
- Total Sleep Time (TST)(Nights 1 and 4)
- Wake After Sleep Onset (WASO) by PSG(Nights 1 and 4)
- Number of Participants with Clinically Significant Physical Examination Abnormalities(Baseline up to end of study (approximately up to 9 weeks))
- Number of Participants with Clinically Significant Laboratory Abnormalities(Baseline up to end of study (approximately up to 9 weeks))
- Total Duration of NREM Sleep(Nights 1 and 4)
- Rapid Eye Movement (REM) Sleep Latency(Nights 1 and 4)
- Total Duration of Rapid Eye Movement (REM) Sleep(Nights 1 and 4)
- Number of Participants with Clinically Significant Vital Signs Abnormalities(Baseline up to end of study (approximately up to 9 weeks))
- Number of participants with suicidal ideation measured using Columbia Suicide Severity Rating Scale (C-SSRS)(Baseline, Days 1, 2, 4, 5, and end of study (approximately 9 weeks))
- Bond-Lader Visual Analog Scales (B-L VAS) Score(Baseline, Day 2, and Day 5)
- Next-Day Residual Effect Measured by the Karolinska Sleepiness Scale (KSS) Score(Baseline, Day 2, and Day 5)
- Residual Effect on a Cognitive Test Battery Evaluated by Symbol Digit Modalities Test (SDMT)(Baseline and Day 5)
- Performance Score on a Cognitive Test Battery Evaluated by Trail Making Test Form B (TMT-B)(Baseline and Day 5)
- Number of Participants with Clinically Significant Electrocardiogram (ECG) Abnormalities(Baseline up to end of study (approximately up to 9 weeks))
- Percentage of Participants with all Serious Adverse Events (SAEs) and Events of Special Interest(Baseline up to end of study (approximately up to 9 weeks))
- Residual Effect on Cognitive Function Measured by Hopkins Verbal Learning Test-Revised (HVLT-R)(Baseline and Day 5)
Investigators
Study Sites (4)
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