A Study to Evaluate Bioavailability, Food Effect, Safety and Tolerability of a Solid Dosage Formulation of JNJ-54861911 in Healthy Older Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine pharmacokinetics (the study of the way a drug
      enters and leaves the blood and tissues over time) and the relative-bioavailability (the
      extent to which a drug or other substance becomes available to the body) of JNJ-54861911
      solid dosage formulation compared with JNJ 54861911 oral suspension formulation in healthy
      older male participants.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label (all
      people know the identity of the intervention), single-center, single-dose and 3-way Crossover
      (the same medications provided to all participants but in different sequence) study to
      determine the bioavailability of JNJ-54861911 solid dosage formulation in healthy older male
      participants. The study will consist of 3 parts: Screening Phase (that is, 28 days before
      study commences on Day 1), an open-label treatment Phase (consists of 3 single-dose treatment
      periods, either a single oral suspension formulation [Treatment A] or solid formulation 25
      milligram (mg) dose of JNJ-54861911 under fasted [Treatment B] or fed conditions [Treatment
      C] in subsequent 3-treatment periods; each treatment period separated with washout period of
      6 days) and follow-up Phase (7 to 14 days after last dose administration). The maximal study
      duration for a participant will not exceed 8 weeks. All the eligible participants will be
      randomly assigned to 1 of the 6 treatment sequences. Followed by an overnight fast of at
      least 10 hours participants will be administered with study treatment under fasted condition
      or fed condition (30 minutes after high-fat, high-calorie breakfast). Participants will not
      be allowed to have food until 4 hours of drug administration. Blood samples will be collected
      for evaluation of pharmacokinetics at pre-dose and post-dose of study treatment.
      Bioavailability will be primarily evaluated by pharmacokinetic parameters. Participants'
      safety will be monitored throughout the study.
    

Intervention name(s): JNJ-54861911 (Treatment A); JNJ-54861911 (Treatment B); JNJ-54861911 (Treatment C)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods.; Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods.; Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Bioavailability; Alzheimer's Disease; JNJ-54861911