Pharmacokinetic Study of JNJ-42756493 in Healthy Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02218073
• Date of registration: 14/08/2014
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: Pharmacokinetic Study of JNJ-42756493 in Healthy Participants
• Scientific title: A Single-Dose, Open-Label, Randomized, Two-Way Crossover Pharmacokinetic Study to Assess the Relative Bioavailability of Orally Administered JNJ-42756493 Following Intake of a Tablet Versus a Solution and to Assess the Absolute Bioavailability of Orally Administered JNJ-42756493 Following Concomitant Administration of an Intravenous Microdose of the Stable Isotope JNJ-61818549 in Healthy Subjects
• Date of first enrolment: October 2014
• Target sample size: 8
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT02218073
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Received a thorough explanation of the optional pharmacogenomic research component of
the study and was offered an opportunity to participate by signing the separate
pharmacogenomic informed consent document

- If a woman, must be postmenopausal (no spontaneous menses for at least 2 years), or
surgically sterile

- If a woman, must have a negative serum beta-human chorionic gonadotropin (hCG)
pregnancy test at screening

- Body mass index (BMI) (weight kilogram [kg]/ height square meter[m^2] between 18 and
30 kg/m^2 (inclusive), and body weight not less than 50 kg

- Non-smoker for at least 6 months before entering the study

Exclusion Criteria:

- 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, renal or hepatic insufficiency, thyroid disease,
neurologic or psychiatric disease, metabolic bone disease (other than osteoporosis),
infection, or any other illness that the investigator considers should exclude the
subject or that could interfere with the interpretation of the study results

- Clinically significant abnormal values for hematology, clinical chemistry or
urinalysis at screening and predose on Day -2 (urinalysis only) and on Day -1 of both
treatment Period as deemed appropriate by the investigator. Retesting of abnormal lab
values that may lead to exclusion will be allowed once

- Clinically significant abnormal physical examination, vital signs or 12-lead
electrocardiogram (ECG) at screening and Day -1 of both treatment Periods as deemed
appropriate by the investigator

- Use of any prescription or nonprescription medication (including vitamins and herbal
supplements), except for paracetamol and hormonal replacement therapy within 14 days
before the first dose of the study drug is scheduled

- History of, or a reason to believe a participant has a history of drug or alcohol
abuse within the past 5 years



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: JNJ-42756493 10 mg Oral Solution

Drug: JNJ-61818549

Drug: JNJ-42756493 10 mg tablet

Primary Outcome(s)

Absolute Bioavailability [Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose]

Relative Bioavailability: Maximum Plasma Concentration (Cmax) [Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose]

Relative Bioavailability: Area under concententration time-curve (AUC) [Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose]

Secondary Outcome(s)

Elimination Half-Life (t1/2) [Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose]

Time to Reach Maximum Concentration (tmax) [Time Frame: Day 1 (pre-dose); 15, 30 and 60 minutes, 2, 3, 4, 6, 8, 12, 16, 24, 32, 48, 72, 96, 120 and 144 hours post-dose]

Secondary ID(s)

2014-002634-31

CR104998

42756493EDI1002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors