major depressive disorder (MDD) and insomnia
Conditions
Interventions
Participant will be given seltorexant as an oral tablet with 240 milliliter
(mL) of water in the evening of Day 1, approximately 3 hours after dinner.
Dinner may be given earlier than one is used to
Sponsors
Janssen-Cilag International NV
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: 1. 18 to 55 years of age, inclusive. 2. Healthy on the basis of medical history at screening and physical examination, vital signs, and 12-lead ECG performed at screening and at admission to the study site on Day -1. 3. Healthy on the basis of clinical laboratory tests performed at screening and at admission to the study site on Day -1. If the results of the clinical chemistry panel, hematology, or urinalysis are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the investigator. One repeat for out-of-range laboratory values is permitted. 4. Body weight not less than 50 kg and body mass index (BMI; weight [kg]/height2 [m]2) within the range 18 kg/m2 and 32 kg/m2 (inclusive). 5. Man or woman
Exclusion criteria
Exclusion criteria: 1. History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency (creatinine clearance below 60 mL/min based on Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation), thyroid disease, kidney or urinary tract disturbances, neurologic or psychiatric disease like MDD, generalized anxiety disorder (GAD), psychotic disorders, infection, seizure disorder, or any other illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results. Significant past gastrointestinal medical history, or any disease/surgery (NOTE: cholecystectomy and appendectomy are not exclusionary) that would interfere with drug absorption. 2. Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening or at admission to the study site (Day -1) as determined by the investigator. Alanine transaminase (ALT)/aspartate transaminase (AST) concentrations within normal range at screening. One retest for ALT/AST is permitted 3. Clinically significant abnormal physical examination, vital signs, or 12-lead ECG at screening or at admission to the study site on Day -1 as determined by the investigator. 4.1 Participant has a current or recent history of serious suicidal ideation within the past 6 months, corresponding to a positive response on item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia-Suicide Severity Rating Scale (C-SSRS), or a lifetime history of suicidal behavior or suicidal attempt as validated by the C-SSRS at screening. 5. Positive test for human immunodeficiency virus (HIV)-1 and HIV-2 antibodies, hepatitis B surface antigen (HBsAg), or hepatitis C antibodies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the absolute bioavailability of seltorexant in healthy participants following a single oral dose of seltorexant and an IV infusion dose of 14C-seltorexant. endpoint: Absolute bioavailability calculated as the ratio of dose normalized AUC of oral and IV administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the PK of seltorexant in healthy participants following a single oral dose of seltorexant and an IV infusion dose of 14C-seltorexant. endpoint: Pharmacokinetic parameters: AUC, Cmax, Tmax, and half-life To assess the safety and tolerability of a single oral dose of seltorexant and an IV infusion dose of 14C-seltorexant. endpoint: adverse events | — |
Countries
Netherlands
Outcome results
None listed