ICON-Groningen-62040
Groningen, 9728 NZ, Netherlands
NCT Number: NCT05738291
Effects of multiple rising doses of BI 1839100 on safety, tolerability, pharmacokinetics and the effect of high-fat meal on pharmacokinetics of BI 1839100 will be assessed as well as assessing potential drug-drug interactions.
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Notify Me18 year–55 year
Male
Interventional
Phase 1
Groningen, 9728 NZ, Netherlands
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
BI 1839100
Placebo matching BI 1839100
midazolam
digoxin
rosuvastatin
Time frame: up to 26 days
Multiple-rising dose (MRD)
Time frame: up to 20 days
Drug-Drug Interaction (DDI)
Time frame: up to 20 days
Time frame: up to 7 days
Time frame: up to 7 days
Time frame: at Day 1
Time frame: at Day 1
Time frame: at Day 1
Time frame: up to 48 hours
Time frame: up to 17 days
Time frame: up to 17 days
Boehringer Ingelheim
Industry
A Phase I Study to Assess Safety, Tolerability, Pharmacokinetics and Effect of Food on Multiple Rising Oral Doses of BI 1839100 (Single-blind, Randomised, Placebo-controlled, Parallel Group Design) and the Effect of Multiple Doses of BI 1839100 on the Single Dose Pharmacokinetics of Cytochrome P450 Substrate (Midazolam), a P Glycoprotein Substrate (Digoxin) and OATP Substrate (Rosuvastatin) Administered Orally (Open-label, Fixed-sequence) in Healthy Male Subjects
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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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