CRS Clinical Research Services Mannheim GmbH
Mannheim, 68167, Germany
NCT Number: NCT03854552
The main objective of this trial is to investigate safety and tolerability of BI 764198 in healthy male subjects following oral administration of single rising doses.
Secondary objectives are the exploration of pharmacokinetics (PK) including dose proportionality of BI 764198 after single oral dosing.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
Mannheim, 68167, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
capsule
Other names: Apecotrep
capsule
Time frame: From drug administration till the end of trial, up to 14 days.
The percentage of subjects with drug-related adverse events (AEs).
Time frame: Within 2 hours (h) prior and 30 minutes (min), 1h, 1h and 30min, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h and 168h following drug administration.
Area under the concentration-time curve of BI 764198 in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞).
Time frame: Within 2 hours (h) prior and 30 minutes (min), 1h, 1h and 30min, 2h, 3h, 4h, 6h, 8h, 12h, 24h, 36h, 48h, 72h, 96h, 120h and 168h following drug administration.
Maximum measured concentration of BI 764198 in plasma (Cmax).
Boehringer Ingelheim
Industry
Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 764198 in Healthy Male Subjects (Single-blind, Partially 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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