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OpenTrials
Completed

NCT Number: NCT07215260

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BI 3000202

Drug

BI 3000202

Rosuvastatin

Drug

Rosuvastatin

Other names: CRESTOR®

Digoxin

Drug

Digoxin

Other names: Lanicor®

Primary outcomes

  1. Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to Day 7

  2. Area under the concentration-time curve of digoxin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)

    Time frame: Up to Day 7

  3. Maximum measured concentration of rosuvastatin in plasma (Cmax)

    Time frame: Up to Day 7

  4. Maximum measured concentration of digoxin in plasma (Cmax)

    Time frame: Up to Day 7

Secondary outcomes

  1. Area under the concentration-time curve of rosuvastatin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Time frame: Up to Day 7

  2. Area under the concentration-time curve of digoxin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    Time frame: Up to Day 7

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

The Effect of BI 3000202 on the Pharmacokinetics of Rosuvastatin and Digoxin Given as a Cocktail - an Open-label, Non-randomised, 2-period Fixed-sequence Trial in Healthy Male and Female Trial Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 10, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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