depression mood disorder
Conditions
Interventions
Aticaprant as reference formulation and concept formulations.
Sponsors
Janssen-Cilag
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: All parts: - Healthy based on physical examination, medical history, clinical laboratory tests, vital signs, and 12-lead ECG. - Body mass index between 18 and 29.9 kg/m2 (inclusive), and body weight not less than 50 kg. - Female subjects should not be pregnant, and either not of childbearing potential or practicing a highly effective method of contraception (see clinical protocol for details). - Blood pressure between 90 mmHg and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic. Part 1, 2 and 3: - Healthy male and female participants between 18 and 55 years of age, inclusive Part 4: - Healthy male and female participants between 55 and 75 years of age, inclusive. See clinical protocol paragraph 5.1 for all inclusion criteria.
Exclusion criteria
Exclusion criteria: - History of or current significant medical illness that the Investigator considers should exclude the participant or that could interfere with the interpretation of the study results. - History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence). - Any known and relevant allergies, hypersensitivity, or intolerances. - Presence of left bundle branch block, atrioventricular block (second degree or higher), or a permanent pacemaker or implantable cardioverter defibrillator. - Clinically-relevant gastrointestinal complaints per clinical judgment or history of documented gastric disease. - Current or past homicidal ideation/intent within the last 6 months, per the investigator*s clinical judgment, or has current or past suicidal ideation with some intent to act within 6 months prior to the start of the screening phase, per the investigator*s clinical judgment or based on the Columbia Suicide Severity Rating Scale (C-SSRS). - Serology positive for hepatitis B surface antigen, hepatitis C virus antibodies or human immunodeficiency virus antibodies at screening. - Use of any prescription or nonprescription medication, except for paracetamol/acetaminophen, hormone-based contraceptives and hormonal replacement therapy within 14 days before the first dose of the study intervention. - Received an investigational intervention or used an invasive investigational medical device within at least 1 month, before the planned first dose of study intervention or is currently enrolled in an investigational study. - Pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention. - Plans to father a child while enrolled in this study or within 90 days after the last dose of study intervention. - Had major surgery within 12 weeks before screening, or will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. - History of substance or alcohol use disorder within 6 months before Screening or positive alcohol and drug screening test. - Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator. - Donated blood or blood products or plasma or had substantial loss of blood (more than 500 mL) within 3 months before the first administration of study intervention in each part of the study or intention to donate blood or blood products during the study. - History of smoking or use of nicotine-containing substances within the previous 3 months prior to screening. - Drinks, on average, more than 8 cups of tea/coffee/cocoa/cola or other caffeinated beverages per day. See section 5.2 of the protocol for all exclusion criteria, including extra exclusion criteria for part 4 of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacogenomics Biomarkers Safety | — |
Countries
Netherlands
Outcome results
None listed