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

Completed · Phase 1 · Has a placebo group

Conditions studied: Sleep Apnea, Obstructive

In brief

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.

Key facts

Study ID: NCT03796026
Run by: Janssen Research & Development, LLC
People needed: 34
Starts: 2019-01-04
Expected to finish: 2019-06-14
Last updated by the study team: 2025-04-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

NeuroTrials Research, Inc. — Atlanta, Georgia, United States
Clinilabs — New York, New York, United States
CTI Clinical Trial and Consulting Services — Cincinnati, Ohio, United States
AMR New Orleans, Formerly New Orleans Center for Clinical Research - New Orleans, an AMR company — Knoxville, Tennessee, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.