A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants
A Single Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-42165279 in Healthy Male Participants
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.
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.
Inclusion Criteria:

 -  Has a body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg.

 -  Must adhere to required contraception (subject and partner, if applicable) during the
 study and for 3 months after study

 -  Must agree to not donate sperm during the study and for 3 months after receiving the
 last dose of study drug

 Exclusion Criteria:

 -  Has history of or current clinically significant medical illness including cardiac
 arrhythmias or other cardiac disease, hematologic disease, coagulation disorders
 (including any abnormal bleeding or blood dyscrasias), lipid abnormalities,
 significant pulmonary disease, including bronchospastic respiratory disease, diabetes
 mellitus, renal or hepatic insufficiency, thyroid disease, neurologic or psychiatric
 disease, infection, recent surgery or trauma.

 -  Has history of malignancy within 5 years before screening (exceptions are squamous and
 basal cell carcinomas of the skin, or malignancy that in the opinion of the
 investigator, with concurrence with the sponsor's medical monitor, is considered cured
 with minimal risk of recurrence)

 -  Has clinically significant abnormal values for hematology, clinical chemistry,
 coagulation, or urinalysis at screening or at first admission to the study center.

 -  Has clinically significant abnormal physical examination, neurological examination,
 vital signs, or 12-lead electrocardiogram (ECG) at screening or at first admission to
 the study center. Subjects with a QTcF interval >450 msec or QRS interval ≥110 msec
 will be excluded.

 -  Has use of any prescription or nonprescription medications or herbal supplements,
 except for paracetamol, within 14 days before the first dose of study drug.
 Paracetamol is not allowed within 1 day (Day -1) before the first dose of study drug.

 -  Has known allergy, hypersensitivity, or intolerance to hypromellose (the excipient of
 JNJ-42165279)

 -  Has Known allergy to heparin or history of heparin induced thrombocytopenia

 -  Has positive test for human immunodeficiency virus (HIV) 1 and 2 antibodies, hepatitis
 B core antibody (HBcAB), hepatitis B surface antigen (HBsAg), or hepatitis C
 antibodies (HCV)

 -  Has history of significant drug or alcohol abuse within past 5 years, or has a
 positive drug screen

 -  Smoking or use of nicotine-containing substances within past 2 months

 -  Blood donation or blood loss within past 3 months

 -  Recent use of an investigational drug or device