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

NCT01690286 | Completed Phase 1

• 2 other identifiers: CR10091538518168ARA1003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy

Keywords

Healthy; Ketoconazole; JNJ-38518168; Pharmacokinetics

Outcome Measures

Primary Outcomes (2)

• The plasma concentrations of JNJ-38518168

  From Day 13 up to Day 26

• The plasma concentrations of ketoconazole

  Day 25

Secondary Outcomes (1)

• The time to attain steady-state pharmacokinetics following JNJ-38518168 once daily doses for 21 consecutive days

  21 days

Study Arms (3)

Group 1: JNJ-38518168 3 mg/ ketoconazole

EXPERIMENTAL

Drug: JNJ-38518168 3 mg; Drug: Ketoconazole 200 mg

Group 2: JNJ-38518168 30 mg/ ketoconazole

EXPERIMENTAL

Drug: JNJ-38518168 30 mg; Drug: Ketoconazole 200 mg

Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)

EXPERIMENTAL

Drug: JNJ-38518168 10 mg; Drug: Ketoconazole 200 mg

Interventions

JNJ-38518168 3 mg DRUG

One oral daily dose of JNJ-38518168 3 mg for 25 days.

Group 1: JNJ-38518168 3 mg/ ketoconazole

JNJ-38518168 30 mg DRUG

One oral daily dose of JNJ-38518168 30 mg for 25 days.

Group 2: JNJ-38518168 30 mg/ ketoconazole

JNJ-38518168 10 mg DRUG

One oral daily dose of JNJ-38518168 10 mg for 25 days.

Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)

Ketoconazole 200 mg DRUG

Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.

Group 1: JNJ-38518168 3 mg/ ketoconazole; Group 2: JNJ-38518168 30 mg/ ketoconazole; Group 3: JNJ-38518168 10 mg/ ketoconazole (optional)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (1)

Unknown Facility

Neptune City, New Jersey, United States

Location

MeSH Terms

Interventions

Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2012
• First Posted: September 21, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 16, 2013

Record last verified: 2013-07

Locations

US (1)