SGS Life Science Services - Clinical Research
Edegem, 2650, Belgium
NCT Number: NCT04666922
The main objectives of this trial are to investigate safety, tolerability, and pharmacokinetics of BI 765080 in healthy male subjects following intravenous administration of single rising doses.
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Edegem, 2650, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BI 765080
Placebo; 0.9% saline for injection
Time frame: Up to 87 days
Percentage of subjects with drug-related adverse events is presented.
Time frame: Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080.
Area under the concentration-time curve of BI 765080 in serum over the time interval from 0 extrapolated to infinity (AUC0-∞) is presented.
Time frame: Within 3 hours (h) prior to administration of BI 765080 and 30 minutes (min), 1h, 2h, 3h, 4h, 6h, 8h, 10h, 12h, 24h, 34h, 48h, 72h, 144h, 312h, 480h, 648h, 1320h and 1992h after administration of BI 765080.
Maximum measured concentration of BI 765080 in serum (Cmax) is presented.
Boehringer Ingelheim
Industry
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Rising Intravenous Doses of BI 765080 in Healthy Male Subjects (Single-blind, Randomised, Placebo-controlled, Parallel-group Design)
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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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