NCT01442532View on ClinicalTrials.gov

A Study of the Safety and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Male Participants and the Effect of JNJ-38518168 on the Blood Levels of Midazolam

PHASE1CompletedINTERVENTIONAL
Enrollment

94

Participants

Timeline

Start Date

September 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Healthy Male Volunteer
Interventions
DRUG

JNJ-38518168 (30 mg)

Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days

DRUG

JNJ-38518168 (10 mg)

Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days

DRUG

JNJ-38518168 (3 mg)

Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days

DRUG

Placebo

Form=tablet, route=oral use, for 14 days

DRUG

Midazolam and JNJ-38518168

Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15

Trial Locations (1)

Unknown

Cypress

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT01442532 - A Study of the Safety and Pharmacokinetics of JNJ-38518168 in Japanese and Caucasian Male Participants and the Effect of JNJ-38518168 on the Blood Levels of Midazolam | Biotech Hunter | Biotech Hunter