A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, pharmacokinetics, and
      pharmacodynamic effects of single oral doses and multiple oral doses of JNJ-38877618
      administered for 7 consecutive days in healthy adult male participants.
    

Detailed description: 
      This is a randomized (individuals assigned to study treatment by chance), double-blind
      (individuals and study personnel will not know the identity of study treatments), placebo (an
      inactive substance that is compared with a drug to test whether the drug has a real effect in
      a clinical trial)-controlled study in healthy adult male participants aged 18 to 45 years (a
      single optional cohort in older healthy male participants aged 50 to 65 years may be
      included). If all optional cohorts are included, up to 144 participants may be enrolled. This
      study will consist of up to four parts. Part 1 contains up to 3 subparts: Part 1a is a
      double-blind, placebo-controlled, single ascending dose design (SAD) with a liquid
      formulation (Formulation A); Part 1b is an open-label (identity of assigned study drug will
      be known), single dose evaluation of a capsule formulation (Formulation B); and Part 1c is an
      optional open-label, single dose evaluation of a capsule formulation (Formulation C). Part 2
      is the completion of the double-blind, placebo-controlled SAD after a formulation has been
      selected based on Parts 1a, 1b, and 1c (if applicable). Part 3 is a double-blind,
      placebo-controlled, multiple ascending dose design (MAD). Doses for Part 3 will be determined
      based on the safety, tolerability, and pharmacokinetics (study of what the body does to a
      drug) in Parts 1 and 2. Part 4 is an optional double-blind, placebo-controlled, single dose
      evaluation in older healthy male participants. Serial pharmacokinetic and pharmacodynamics
      (study of what a drug does to the body) samples will be collected and safety will be
      monitored throughout the study.
    

Intervention name(s): JNJ-38877618: Part 1a; JNJ-38877618: Part 1b; JNJ-38877618: Part 1c (optional); JNJ-38877618: Part 2; JNJ-38877618: Part 3; JNJ-38877618: Part 4 (optional); Placebo: Parts 1a, 2, 3, and 4 (optional)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.; Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.; Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.; Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.; Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.; Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.; Administered orally matched to study drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; JNJ-38877618; Pharmacokinetic; Safety; Single-ascending dose; Multiple-ascending dose