Peking Union Medical College Hospital
Beijing, 100032, China
NCT Number: NCT05633862
The main objectives of this trial are to investigate pharmacokinetics, safety and tolerability of BI 1015550 in Chinese healthy male and female subjects following administration of single doses.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Beijing, 100032, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Chinese subjects will only be included in the trial if they meet the following criteria:
Exclusion criteria
Subjects will not be allowed to participate, if any of the following general criteria apply:
A single film-coated tablet BI 1015550 taken orally after an overnight fast of at least 10 hours.
Other names: Nerandomilast, JASCAYD®
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Within 3 hours before and 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120 and 144 hours following drug administration.
Maximum measured concentration of BI 1015550 in plasma (Cmax).
Time frame: Up to 7 days.
Number of subjects with any treatment-emergent adverse event (AE).
Boehringer Ingelheim
Industry
Pharmacokinetics, Safety and Tolerability of Doses of BI 1015550 in Healthy Chinese Male and Female Subjects (Open-label, 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.
NCT06068257
Breast Cancer, Breast Diseases
Orlando, Florida, United States
View Trial DetailsNCT06702423
Healthy
London, United Kingdom
View Trial DetailsNCT07223164
Healthy
Irvine, California, United States
View Trial DetailsNCT05595902
Healthy
Kadıköy, Istanbul, Turkey (Türkiye)
View Trial Details