SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004, Japan
NCT Number: NCT03793621
The main objective of this trial is to investigate the safety and tolerability of BI 730357 in Japanese healthy male subjects following oral administration of single rising doses.
Secondary objectives are the explorations of the pharmacokinetic(s) (PK), including dose proportionality as well as investigation of linearity of BI 730357 after single dose administration.
Looking for future studies?
Notify Me20 year–45 year
Male
Interventional
Phase 1
Tokyo, Sumida-ku, 130-0004, Japan
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
-- born in Japan, have lived outside of Japan <10 years, and have parents and grandparents who are Japanese
--- combined oral contraceptives, intrauterine device.
Exclusion criteria
single rising oral dose
single rising oral dose
Time frame: Up to 7 days after drug administration.
Number of participants with trial drug-related adverse events.
Time frame: Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.
Area under the concentration-time curve of BI 730357 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Within 3 hours before drug administration and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 24, 34, 48, 72, 96 and 168 hours after drug administration.
Maximum measured concentration of BI 730357 in plasma (Cmax).
Boehringer Ingelheim
Industry
Safety, Tolerability, and Pharmacokinetics of Single Rising Oral Doses of BI 730357 in Japanese Healthy Male Subjects (Double-blind, Randomised, Placebo-controlled, Parallel Group Design)
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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