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A Study to Evaluate the Bioavailability and Food Effect of JNJ-39439335 in Healthy Adult Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01454245
First received: July 14, 2011
Last updated: January 30, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Healthy
 Drug: JNJ-39439335
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
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

Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Pharmacokinetic parameters (Area Under the Curve [AUC]) of JNJ-39439335 [ Time Frame: 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. ] [ Designated as safety issue: No ]
  • Maximum plasma concentration [Cmax]) of JNJ-39439335 [ Time Frame: Up to approximately 70 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcome measures are reported

Enrollment: 43
Study Start Date: July 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001

JNJ-39439335 Part 1:Type=1 unit=mg number=25 form=capsule route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods.

or Part 1:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.,JNJ-39439335 Part 2:Type=2 unit=mg number=12.5 form=capsule route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods.

 Drug: JNJ-39439335
Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods.
Drug: JNJ-39439335

Part 1:Type=1, unit=mg, number=25, form=capsule, route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods.

or Part 1:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods.

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

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01454245

Locations
United States, Kansas
Overland Park, Kansas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01454245     History of Changes
Other Study ID Numbers: CR018676, 39439335
Study First Received: July 14, 2011
Last Updated: January 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
39439335EDI1013
Bioavailability
Pharmacokinetics

ClinicalTrials.gov processed this record on May 23, 2013