Clinical trial NCT01454245: A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers
Official title: An Open-Label, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of JNJ-39439335 Capsule Formulations Administered as a Single Oral Dose in Healthy Male Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: 39439335EDI1013
Bioavailability
Pharmacokinetics
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2011-10-18
Enrollment: 43
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study is to evaluate the pharmacokinetics and relative bioavailability of a single dose of 3 capsule formulations of JNJ-39439335 in healthy adult male volunteers. The effect of food on the pharmacokinetics of one of the capsule formulations of JNJ-39439335 will also be evaluated during the study.

Detailed description: This is an open-label (the name of the study drug will be known to the healthy volunteers participating in this study as well as to all study staff), randomized (volunteers will be assigned by chance to 1 of 6 possible treatment sequences of a single dose of 3 different capsule formulations of JNJ-39439335) to evaluate the pharmacokinetics (blood levels of drug) and relative bioavailability (i.e., the rate and extent of absorption of the drug in the body) of JNJ-39439335 (Part 1 of the study). The effect of food on the administration of JNJ-39439335 will then be evaluated on 1 capsule formulation of JNJ-39439335 (Part 2 of the study). The safety and tolerability of JNJ-39439335 will be monitored throughout Part 1 and 2 of the study. In Part 1, healthy volunteers will be randomly assigned to 1 of 6 treatment sequences and will receive a total of 3 single doses of JNJ-39439335. Each dose (2 capsules) will be separated by 21 days. In Part 2, healthy volunteers will be randomly assigned to 1 of 2 treatment sequences and will receive a total of 2 single doses of one formulation selected from Part 1; each dose will be separated by 21 days. Doses will be administered to healthy volunteers under fed and fasted conditions.

Eligibility criteria: Inclusion Criteria:

* Signed an informed consent document indicating they understand the purpose of and procedures required for the study and are willing to participate in the study
* Agree to use an adequate contraception method as deemed appropriate by the investigator (e.g., vasectomy, double-barrier, partner using effective contraception) and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
* Have a body mass index (weight \[kg\]/height2 \[m\]2) (BMI) between 18 and 30 kg/m2 (inclusive), body weight not less than 50 kg, blood pressure (after sitting for 5 minutes) between 90 and 140 mmHg, systolic, inclusive, and no higher than 90 mmHg diastolic, and an electrocardiogram with results consistent with normal cardiac conduction and function
* Non-smoker for at least 3 months

Exclusion Criteria:

* History of or current medical illness, laboratory values, vital signs, physical examination findings, or electrocardiogram findings deemed clinically significant by the Investigator

Primary outcomes:
measure: Pharmacokinetic parameters (Area Under the Curve [AUC]) of JNJ-39439335
timeFrame: Up to approximately 70 days (14 days after each of 3 doses of study drug in Part I of the study and after each of 2 doses in Part 2 of the study.
measure: Maximum plasma concentration [Cmax]) of JNJ-39439335
timeFrame: Up to approximately 70 days
Secondary outcomes:
measure: No secondary outcome measures are reported
Other outcomes:
Locations:
city: Overland Park
country: United States
state: Kansas
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC C. Clinical Trial
role: STUDY_DIRECTOR
References: