A Phase I Study to Assess Safety, Tolerability, Pharmacokinetics and Effect of Food on Multiple Rising Oral Doses of BI 1839100 (Singleblind, 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
Latest Information Update: 18 Nov 2024
At a glance
- Drugs BI 1839100 (Primary) ; Digoxin; Midazolam; Rosuvastatin
- Indications Pulmonary fibrosis
- Focus Adverse reactions; Pharmacokinetics
- Sponsors Boehringer Ingelheim
Most Recent Events
- 13 Jun 2024 Status changed from recruiting to completed.
- 25 Mar 2024 Planned number of patients changed from 58 to 68.
- 04 Mar 2024 Planned End Date changed from 31 May 2024 to 7 Jun 2024.