A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants

PHASE1CompletedINTERVENTIONAL
Enrollment

84

Participants

Timeline

Start Date

November 30, 2013

Primary Completion Date

May 31, 2014

Study Completion Date

May 31, 2014

Conditions
Healthy Volunteers
Interventions
DRUG

JNJ-38877618: Part 1a

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.

DRUG

JNJ-38877618: Part 1b

Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.

DRUG

JNJ-38877618: Part 1c (optional)

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.

DRUG

JNJ-38877618: Part 2

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.

DRUG

JNJ-38877618: Part 3

Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.

DRUG

JNJ-38877618: Part 4 (optional)

Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.

DRUG

Placebo: Parts 1a, 2, 3, and 4 (optional)

Administered orally matched to study drug

Trial Locations (1)

Unknown

Nottingham

All Listed Sponsors
lead

Janssen Cilag N.V./S.A.

INDUSTRY

NCT01964872 - A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-38877618 in Healthy Male Participants | Biotech Hunter | Biotech Hunter