The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose and multiple dose administrations of JNJ-40411813 in Japanese healthy adult male participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Enrollment
39
JNJ-40411813 will be administered orally.
Matching placebo will be administered orally.
Souseikai Fukuoka Mirai Hospital
Fukuoka, Japan
Parts 1 and 2: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 6 weeks
Part 3: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Time frame: Up to 8 weeks
Parts 1 and 2: Plasma Concentration of JNJ-40411813
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
Time frame: Predose, up to 96 hours postdose (Day 5)
Part 3: Plasma Concentration of JNJ-40411813
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive LC-MS/MS.
Time frame: Predose, up to 312 hours postdose (Day 14)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.