A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00915746
First received: June 4, 2009
Last updated: April 29, 2010
Last verified: April 2010

June 4, 2009
April 29, 2010
November 2009
Not Provided
The primary objective is to assess the effects of repeated daily administration of 400 mg of ketoconazole on the single-dose pharmacokinetics of JNJ-31001074 in healthy volunteers [ Time Frame: Multiple blood samples will be obtained over the 11 day open-label treatment phase ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00915746 on ClinicalTrials.gov Archive Site
To assess the safety and tolerability of JNJ-31001074 with and without coadministration of ketoconazole [ Time Frame: up to 32 days (including a 21 day screening phase) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
A Drug Interaction Study of JNJ-31001074 and Ketoconazole in Healthy Volunteers
An Open-Label Drug-Drug Interaction Study to Assess the Effect of Ketoconazole on the Pharmacokinetics of JNJ-31001074 in Healthy Subjects

This is an open-label (both the physician and healthy volunteer know which treatment will be administered) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of study/early withdrawal assessment phase.

This is an open-label (both the physician and healthy volunteer know which treatment will be administered), sequential design (one after the other) study to assess the pharmacokinetics (process by which JNJ-31001074 is absorbed, distributed, metabolized, and eliminated by the body) of JNJ-31001074 when taken alone and in combination with ketoconazole. The study consists of three phases: a screening phase to determine eligibility, an open-label treatment phase consisting of three periods and an end-of-study/early withdrawal assessment phase. During the screening phase, healthy volunteers will be evaluated to see if they meet selection criteria as specified in the protocol. Healthy volunteers who meet these criteria will report to the study center on Day -1. Volunteers will be admitted to the study center and will fast (no food or beverages) overnight for at least 10 hours. Volunteers will remain at the study center for 11 days. The open-label treatment phase consists of three periods. In Period 1, a single-dose of JNJ-31001074 10 mg will be administered on Day 1, followed by three days of multiple blood sampling (Days 1-3). In Period 2 (Days 4-6), 400 mg ketoconazole will be administered on each day just prior to which predose blood samples are taken. In Period 3 (Days 7-11), JNJ-31001074 10 mg and ketoconazole 400 mg will be administered together on Day 7, followed by four days of multiple blood sampling. Ketoconazole will also be administered on Day 8 and Day 9 of Period 3. No study drug will be administered on Days 2 and 3 of Period 1, and Days 10 and 11 of Period 3. The end-of-study phase assessments will be performed after the completion of the four day blood sampling on Day 11. Safety and tolerability will be assessed throughout the volunteer's participation. Volunteers will be instructed to report any adverse events that occur up to 30 days after their last dose of study drug. The maximum study duration for each volunteer is expected to be 32 days. JNJ-31001074 10 mg will be administered orally on Days 1 and 7; ketoconazole 400 mg will be administered orally on Days 4, 5, 6, 7, 8, and 9.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
  • Healthy
  • Pharmacokinetics
  • Drug Interactions
Drug: JNJ-31001074; ketoconazole
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
December 2009
Not Provided

Inclusion Criteria:

  • healthy volunteer between the ages of 18-55
  • if a woman, must be of non childbearing potential (ie, post menopausal or surgically sterile) and have a negative pregnancy test
  • body mass index between 18-30
  • body weight greater than or equal to 50 kilograms
  • blood pressure between 90 and 140 mgHg systolic and no higher than 90 mgHg diastolic
  • nonsmoker

Exclusion Criteria:

  • History of or current clinically significant medical illness
  • clinically significant abnormal laboratory value(s)
  • clinically significant abnormal physical examination, vital signs or electrocardiogram
  • pregnant, lactating or completed last term pregnancy within six months of screening
  • use of any prescription or non prescription medication except for paracetamol (acetaminophen/TYLENOL), bisphosphonates (drugs to treat osteoporosis), hormone replacement therapy within 14 days of first dose of study medication
  • history of drug or alcohol abuse
  • history of smoking or use of nicotine-containing substances within the previous two months
Both
18 Years to 55 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00915746
CR016342
Not Provided
Clinical Leader, Psychiatry, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Not Provided
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP