A Study to Assess Effects of Clarithromycin on Pharmacokinetics of JNJ-54861911 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effects of strong cytochrome P450 (CYP) 3A4
      inhibitors (Itraconazole and Clarithromycin), on pharmacokinetics (PK) (study of the way a
      drug enters and leaves the blood and tissues over time) of single dose of JNJ-54861911 in
      healthy male participants.
    

Detailed description: 
      This is a single-center, open-label (participants and researchers are aware about the
      treatment, participants are receiving), fixed-sequence study in healthy male participants
      consisting of 2 sequential parts. For all participants enrolled in either part, the study
      consists of 3 phases: Screening Phase (within 21 to 2 days prior to the first dose
      administration on Day 1), Open-label Treatment Phase (Day 1 up to Day 12), and Follow-up
      Phase (7 to 14 days after last dose administration). The maximum duration of study will be 7
      weeks per participant. Study will be conducted in 2 parts to understand the relative role of
      CYP3A4 and amide hydrolysis pathways in JNJ-54861911 metabolism and any potential drug-drug
      interaction liability with inhibitors of these pathways. Itraconazole will be administered in
      Part 1 as mixed CYP3A4 and potential amide hydrolysis inhibitor. Clarithromycin will be
      administered in Part 2 as a pure CYP3A4 inhibitor. However, Part 2 of the study will only be
      conducted if a relevant interaction is observed with itraconazole based on an interim review
      of Part 1 data. Participants enrolled in Part 1 will receive single dose of JNJ-54861911, 25
      milligram (mg) tablet orally on Day 1 and Day 9 along with itraconazole 200 mg (2*100 mg
      capsule) orally once daily from Day 5 to Day 12. Participants enrolled in Part 2 will receive
      single dose of JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9 along with clarithromycin
      500 mg immediate release tablet orally twice daily from Day 5 to Day 12. Blood samples will
      be collected pre-dose (Day 1) up to Day 13 to understand the PK characteristics of
      JNJ-54861911 and diaminothiazine (DIAT, a metabolite formed after amide hydrolysis of
      JNJ-54861911). In addition, a blood sample will be collected on Day -1 from all enrolled
      participants to study genotyping of CYP3A4 gene and other genetic factors that may influence
      the PK, safety, and/or tolerability of JNJ-54861911 and CYP3A4 inhibitors. Participants'
      safety will be monitored throughout the study.
    

Intervention name(s): JNJ-54861911, 25 mg; Itraconazole 200 mg; Clarithromycin 500 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9.; Itraconazole 200 mg (2*100 mg capsule) orally once daily from Day 5 to Day 12.; Clarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12.
Intervention MeSH terms: Clarithromycin; Itraconazole
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; JNJ-54861911; Cytochrome P450 3A4 inhibitor; Itraconazole; Clarithromycin; Alzheimer's disease