SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004, Japan
NCT Number: NCT06139302
The main objectives of this trial are to investigate pharmacokinetics (PK) of R-BI 1015550 in Japanese healthy male subjects following oral administration of two different single BI 1015550 doses.
Looking for future studies?
Notify Me18 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
Exclusion criteria
Participants were administered a single film-coated tablet of nerandomilast (Formulation C1), orally with 240 milliliters (mL) of water after an overnight fast of at least 10 hours (h).
Other names: BI 1015550, JASCAYD®
Time frame: Within 3 hours (hrs) before drug intake and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hrs after drug intake.
Area under the concentration-time curve of nerandomilast in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is reported.
Time frame: Within 3 hours (hrs) before drug intake and at 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hrs after drug intake.
Maximum measured concentration (Cmax) of nerandomilast in plasma is reported.
Boehringer Ingelheim
Industry
Pharmacokinetics of R-BI 1015550 After Single Oral Doses of BI 1015550 in Japanese Healthy Male Subjects (Open-label, Non-randomised, and 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.
Published trials that share one or more normalized conditions with this study.
NCT07724015
Healthy
Jaén, Spain
View Trial DetailsNCT07404254
Beverage Intake, Caffeine
San Francisco, California, United States
View Trial DetailsNCT07466667
Healthy
Ahmedabad, Gujarat, India
View Trial DetailsNCT07357818
Beverage Intake, Caffeine
San Francisco, California, United States
View Trial Details