Souseikai Hakata Clinic
Fukuoka, 812-0025, Japan
NCT Number: NCT04713930
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) after single dose administrations of JNJ-61393215 in Japanese healthy adult male participants.
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Notify Me20 year–55 year
Male
Interventional
Phase 1
Fukuoka, 812-0025, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-61393215 will be administered orally.
Other names: Orexin-1
Placebo will be administered orally.
Time frame: Up to 42 days
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 (up to Day 5)
Plasma samples will be analyzed to determine concentrations of JNJ-61393215 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
Janssen Pharmaceutical K.K.
Industry
A Randomized, Placebo-controlled, Double-blind, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ-61393215 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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