Souseikai Fukuoka Mirai Hospital
Fukuoka, 813-0017, Japan
NCT Number: NCT04677530
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.
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Notify Me20 year–55 year
Male
Interventional
Phase 1
Fukuoka, 813-0017, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-40411813 will be administered orally.
Matching placebo will be administered orally.
Time frame: Up to 6 weeks
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
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: Predose, up to 96 hours postdose (Day 5)
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 312 hours postdose (Day 14)
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive LC-MS/MS.
Janssen Pharmaceutical K.K.
Industry
A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose and Multiple Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-40411813 in Healthy Japanese Adult Male Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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