NCT05738291

A Study in Healthy Men to Test How Well Multiple Doses of BI 1839100 Are Tolerated and How BI 1839100 Influences the Amount of Other Medicines in the Blood

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: Male
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	BI 1839100	BI 1839100
DRUG	Placebo matching BI 1839100	Placebo matching BI 1839100
DRUG	midazolam	midazolam
DRUG	digoxin	digoxin
DRUG	rosuvastatin	rosuvastatin

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-06-14
• Completion: 2024-06-14
• First posted: 2023-02-22
• Last updated: 2024-11-13

Locations

1 site across 1 country: Netherlands