SOUSEIKAI Sumida Hospital
Tokyo, Sumida-ku, 130-0004, Japan
NCT Number: NCT03542344
The primary objective of this trial is to investigate the safety and tolerability of BI 1015550 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality of BI 1015550 after single dosing.
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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
Exclusion criteria
Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device or hormonal contraceptive since at least two months)
In addition, the following trial-specific exclusion criteria apply:
Single rising oral dose
Other names: Nerandomilast, JASCAYD®
Single rising oral dose
Time frame: From drug administration until end of study, up to 9 days
Number of participants with drug-related adverse events is presented.
Time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 hours after drug administration.
Area under the concentration-time curve of the BI 1015550 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) is presented.
Time frame: Within 3 hours before and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 4, 6, 8, 12, 24, 34, 48, 72, 96, 120 hours after drug administration.
Maximum measured concentration of the BI 1015550 in plasma (Cmax) is presented.
Boehringer Ingelheim
Industry
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Japanese 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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