A Study in Healthy People to Test Whether BI 3000202 Affects How 2 Other Medicines (Rosuvastatin and Digoxin) Are Taken up in the Body

Not Applicable

Not yet recruiting

• Conditions: Healthy
• Interventions: Drug: BI 3000202; Drug: Rosuvastatin; Drug: Digoxin

• Registration Number: NCT07215260
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The objective of this trial is to assess the effect of BI 3000202 on the pharmacokinetics of rosuvastatin and digoxin given as a cocktail.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-09
• Study First Submitted: 2025-10-09
• Study First Submitted QC: 2025-10-09
• Last Update Submitted: 2025-10-09
• Study First Posted: 2025-10-10
• Last Update Posted: 2025-10-10
• Study Start: 2025-11-04
• Primary Completion: 2025-11-28
• Study Completion: 2025-12-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• Healthy male or female trial participant according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (blood pressure BP, pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 kg / m^2 (inclusive)
• Signed and dated written informed consent in accordance with international council for harmonisation-good clinical practice (ICH-GCP) and local legislation prior to admission to the trial
• Further inclusion criteria apply.

Exclusion Criteria

• Any finding in the medical examination (including BP, PR or ECG) deviating from normal and assessed as clinically relevant by the investigator
• Repeated measurement of systolic blood pressure outside the range of 90 to 140 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 beats per minute (bpm)
• Any laboratory value outside the reference range that the investigator considers to be of clinical relevance
• Any evidence of a concomitant disease assessed as clinically relevant by the investigator
• Further exclusion criteria apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cocktail (Reference) then BI 3000202-Cocktail (Test)	BI 3000202	Cocktail consisting of rosuvastatin and digoxin.
Cocktail (Reference) then BI 3000202-Cocktail (Test)	Rosuvastatin	Cocktail consisting of rosuvastatin and digoxin.
Cocktail (Reference) then BI 3000202-Cocktail (Test)	Digoxin	Cocktail consisting of rosuvastatin and digoxin.

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 7
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to Day 7
Maximum measured concentration of rosuvastatin in plasma (Cmax)	Up to Day 7
Maximum measured concentration of digoxin in plasma (Cmax)	Up to Day 7

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to Day 7
Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to Day 7

Trial Locations

Locations (1)

Humanpharmakologisches Zentrum Biberach; 🇩🇪 Biberach, Germany