A Study to Assess the Effect of Seltorexant Compared to Placebo on Respiration During Sleep in Adult Participants With Obstructive Sleep Apnea

NCT03796026 | Completed Phase 1 DMC FDA Drug

• 2 other identifiers: CR10857642847922MDD1010
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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.

Conditions

Sleep Apnea, Obstructive

Outcome Measures

Primary Outcomes (1)

• Apnea-Hypopnea Index (AHI) Score as Measured by Polysomnography (PSG)

  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.

  Day 4

Secondary Outcomes (24)

• AHI Score as Measured by PSG

  Day 1 (Night)

• Mean Oxygen Saturation (SpO2) During Total Sleep Time (TST)

  Nights 1 and 4

• Mean SpO2 During Rapid Eye Movement (REM), Non-Rapid Eye Movement (NREM), and Awake Stages

  Nights 1 and 4

• Percentage of Total Sleep Time with SpO2 less than 90 percent (%), 85%, and 80%

  Nights 1 and 4

• Mean Latency to Persistent Sleep (LPS) as Assessed by PSG

  Nights 1 and 4

Study Arms (2)

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.

Drug: Seltorexant 40 mg; Drug: Placebo

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.

Drug: Seltorexant 40 mg; Drug: Placebo

Interventions

Seltorexant 40 mg DRUG

Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.

Also known as: JNJ-42847922

Placebo Followed by Seltorexant; Seltorexant Followed by Placebo

Placebo DRUG

Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.

Placebo Followed by Seltorexant; Seltorexant Followed by Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (4)

NeuroTrials Research, Inc.

Atlanta, Georgia, 30342, United States

Location

Clinilabs

New York, New York, 10019, United States

Location

CTI Clinical Trial and Consulting Services

Cincinnati, Ohio, 45212, United States

Location

AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company

Knoxville, Tennessee, 37923, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

seltorexant

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 8, 2019
• Study Start: January 4, 2019
• Primary Completion: June 7, 2019
• Study Completion: June 14, 2019
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (4)