Effect of Ketoconazole on the Pharmacokinetics of JNJ-38518168 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): JNJ-38518168 3 mg; JNJ-38518168 30 mg; JNJ-38518168 10 mg; Ketoconazole 200 mg
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): One oral daily dose of JNJ-38518168 3 mg for 25 days.; One oral daily dose of JNJ-38518168 30 mg for 25 days.; One oral daily dose of JNJ-38518168 10 mg for 25 days.; Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.
Intervention MeSH terms: Ketoconazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Ketoconazole; JNJ-38518168; Pharmacokinetics