NL-OMON50169CompletedNot Applicable
A Phase 1, Open-Label, Multicenter Study to Evaluate Relative Bioavailability, Pharmacokinetics, Dose Proportionality, Food Effect After Single-Dose Administration of JNJ-67953964 (aticaprant) in Healthy Adult Participants Using reference and concept Formulations. - 67953964MDD1003
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Janssen-Cilag
- Enrollment
- 80
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 99 (—)
Inclusion Criteria
- •- 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
- •- Healthy male and female participants between 55 and 75 years of age,
- •See clinical protocol paragraph 5.1 for all inclusion 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.
Investigators
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