A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants
Condition: Healthy Volunteers; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of
      single ascending doses as well as repeated doses of JNJ-42165279 in healthy male
      participants.
    

Detailed description: 
      This is a single-site, randomized (participants are assigned to treatment by chance),
      double-blind study (neither physician nor participant knows whether the participant is
      receiving active treatment or placebo). Placebo is an inactive substance that is compared
      with a drug to test whether the drug has a real effect. This study consists of two parts
      (part 1, single dosing and part 2, multiple dosing). Part 1: An alternating panel design will
      be used, whereby the first panel of 9 participants will receive the first, third, and fifth
      administered doses, while the second panel of 9 participants will receive the second, fourth,
      and sixth administered doses.Up to 2 additional dosings (1 per panel) may be evaluated to
      further understand the study drug. For each dose administration, 6 participants will be
      assigned to active treatment and 3 to placebo. Each participant will receive JNJ-42165279 on
      2 occasions and placebo once during the first 3 dosings. The planned doses of JNJ-42165279
      range from 2.5 to 500 mg. The sponsor and investigator will review blinded data associated
      with each dose prior to administration of the next dose. Participants will check into the
      study center the morning prior to each dosing (Day -1) and will remain at the center until
      discharge 72 hours after dosing (Day 4). Participants will be dosed approximately every 4
      weeks. Part 2: A separate cohort of 9 healthy male volunteers will receive repeated daily
      dosing of 100 mg JNJ-42165279 or placebo (6 participants will receive JNJ-42165279 and 3
      participants will receive placebo) for 6 consecutive days. Participants will check into the
      study center the morning prior to their first dosing (Day -1) and will remain at the center
      until discharge 72 hours after receiving their last dose on Day 6. Participants in Part 1 and
      2 will return for a follow-up visit 7 to 14 days after their final discharge from the study
      center.
    

Intervention name(s): JNJ-42165279 2.5 - 500 mg oral; Placebo; JNJ-42165279 100 mg oral
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally.; Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.; Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.
Intervention MeSH terms: JNJ-42165279
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy volunteers; Pharmacokinetics; Free fatty amides