1344.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
NCT Number: NCT02044406
To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)
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Notify Me18 year–50 year
Male
Interventional
Phase 1
Ingelheim, Germany
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
single dose (low to high dose)
powder for oral solution
tablet, fasted
Placebo to BI 1181181
tablet, fed
Time frame: up to 72 h
Time frame: up to 72 h
Time frame: up to 72 h
Time frame: up to 72 h
Time frame: up to 72 h
Time frame: up to 72 h
Time frame: up to 72 h
Time frame: up to 72 h
Boehringer Ingelheim
Industry
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers in a Partially Randomised, Single-blind, Placebo-controlled Trial, and Investigation of Relative Bioavailability and the Effect of Food on the Pharmacokinetics of BI 1181181(Open-label, Randomised, Three-way Cross-over 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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