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.
- Conditions
- depressionmood disorder10027946
- Registration Number
- NL-OMON50169
- Lead Sponsor
- Janssen-Cilag
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 80
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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics</p><br>
- Secondary Outcome Measures
Name Time Method <p>Pharmacogenomics<br /><br>Biomarkers<br /><br>Safety</p><br>