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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01690286

Run by

Janssen Research & Development, LLC

People needed

33

Starts

2012-10-01

Expected to finish

2012-12-01

Last updated by the study team

2013-07-16

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

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

Where it is running

• Study site — Neptune City, New Jersey, United States

Full record on ClinicalTrials.gov

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