Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01690286
First received: September 19, 2012
Last updated: July 15, 2013
Last verified: July 2013
  Purpose

The purpose of this study is to evaluate the effects of repeated twice-daily administration of 200 mg ketoconazole on the steady-state pharmacokinetics of JNJ-38518168.


Condition Intervention Phase
Healthy
Drug: JNJ-38518168 3 mg
Drug: JNJ-38518168 30 mg
Drug: JNJ-38518168 10 mg
Drug: Ketoconazole 200 mg
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-Label Study to Assess the Effects of Repeated Twice-Daily Doses of Ketoconazole on the Steady-State Pharmacokinetics of JNJ-38518168 in Healthy Subjects

Resource links provided by NLM:


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

Primary Outcome Measures:
  • The plasma concentrations of JNJ-38518168 [ Time Frame: From Day 13 up to Day 26 ] [ Designated as safety issue: No ]
  • The plasma concentrations of ketoconazole [ Time Frame: Day 25 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The time to attain steady-state pharmacokinetics following JNJ-38518168 once daily doses for 21 consecutive days [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: October 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group 1: JNJ-38518168 3 mg/ ketoconazole Drug: JNJ-38518168 3 mg
One oral daily dose of JNJ-38518168 3 mg for 25 days.
Drug: Ketoconazole 200 mg
Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.
Experimental: Group 2: JNJ-38518168 30 mg/ ketoconazole Drug: JNJ-38518168 30 mg
One oral daily dose of JNJ-38518168 30 mg for 25 days.
Drug: Ketoconazole 200 mg
Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.
Experimental: Group 3: JNJ-38518168 10 mg/ ketoconazole (optional) Drug: JNJ-38518168 10 mg
One oral daily dose of JNJ-38518168 10 mg for 25 days.
Drug: Ketoconazole 200 mg
Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.

Detailed Description:

This is an open-label (all people know the identity of the intervention), single-sequence, randomized (dose of JNJ-38518168 (3 mg or 30 mg) is assigned by chance), single-center, multiple-dose study designed to assess the potential effects of multiple oral administration of ketoconazole (KTZ) on the steady-state (a situation where the overall intake of a drug is in equilibrium with its elimination) pharmacokinetics of JNJ-38518168. Pharmacokinetics (PK) explores how the drug is absorbed in the body, distributed within the body, and how it is removed from the body over time. The study consists of 3 phases: a Screening Phase of approximately 3 weeks (Days -22 to -2); an Open-Label Phase (Days -1 to 26); and a Follow-up Phase occurring from 7 to 10 days after the last dose of study drug. Participants will be randomly assigned to receive either a daily dose of 3 mg JNJ-38518168 (Group 1) or a daily dose of 30 mg JNJ-38518168 (Group 2) orally administered for 25 days. All participants will receive multiple oral doses of KTZ (200 mg every 12 hours for both Groups 1 and 2) from Day 22 through Day 25. An optional group of participants receiving 10 mg once daily of JNJ-38518168 (Group 3) may be evaluated if the data from Groups 1 and 2 do not allow the sponsor to estimate sufficiently the interaction between KTZ and daily dose of 10 mg JNJ-38518168. The participants will receive an oral dose of the study drugs in the morning of specified days, after an overnight fast for at least 10 hours. Blood samples will be collected at various times throughout the study for evaluation of drug concentrations in plasma. Safety will be assessed by reporting of adverse events, vital signs, physical examination results, weight, and electrocardiogram (ECG) evaluations. Participants will leave the study center on Day 26 after the collection of the last scheduled PK blood sample. For each participant, a follow-up visit will occur 7 to 10 days after the last dose of study drug. For each participant, the total duration of the study is approximately 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Signed informed consent document indicating that the participant understands the purpose of and procedures required for the study and is willing to participate in the study
  • If a woman, must be postmenopausal, surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control before, throughout, and for 3 months after the study
  • If a man, must agree to use an adequate contraception method, or partner using effective contraception, and to not donate sperm during the study and for 3 months after the study
  • Body mass index (BMI; weight [kg]/height2 [m]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg
  • Blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
  • Non-smoker

Exclusion Criteria:

  • History of or current clinically significant medical illness, condition or disease that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
  • Clinically significant abnormal lab results at screening or at admission to the study center
  • Clinically significant abnormal physical examination or electrocardiogram (ECG) at screening or at admission to the study center
  • Use of any prescription or nonprescription medication (including vitamins and herbal supplements), except for acetaminophen and oral contraceptives and hormonal replacement therapy within 14 days before the first dose of study drug is scheduled
  • Has a history of malignancy (the tendency of a medical condition, especially tumors, to become progressively worse) within the previous 5 years before screening (certain less serious malignancies during the previous 5 years, such as basal cell carcinoma of the skin which has been adequately treated, may be allowed by the study doctor)
  • Donated blood or had a substantial loss of blood within 3 months before first administration of study drug
  • Pregnant or currently breast-feeding
  • Smoking or using nicotine-containing products within 3 months of screening
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01690286

Locations
United States, New Jersey
Neptune, New Jersey, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01690286     History of Changes
Other Study ID Numbers: CR100915, 38518168ARA1003
Study First Received: September 19, 2012
Last Updated: July 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Healthy
Ketoconazole
JNJ-38518168
Pharmacokinetics

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014