NCT07215260

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Nov 2025

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2025

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2025

Completed
26 days until next milestone

Study Start

First participant enrolled

November 5, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 18, 2025

Completed
Last Updated

December 22, 2025

Status Verified

December 1, 2025

Enrollment Period

1 month

First QC Date

October 9, 2025

Last Update Submit

December 19, 2025

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

Cocktail (Reference) then BI 3000202-Cocktail (Test)

EXPERIMENTAL

Cocktail consisting of rosuvastatin and digoxin.

Drug: BI 3000202Drug: RosuvastatinDrug: Digoxin

Interventions

BI 3000202DRUG

BI 3000202

Cocktail (Reference) then BI 3000202-Cocktail (Test)
RosuvastatinDRUG

Rosuvastatin

Also known as: CRESTOR®
Cocktail (Reference) then BI 3000202-Cocktail (Test)
DigoxinDRUG

Digoxin

Also known as: Lanicor®
Cocktail (Reference) then BI 3000202-Cocktail (Test)

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Humanpharmakologisches Zentrum Biberach

Biberach, 88397, Germany

Location

Related Links

MeSH Terms

Interventions

Rosuvastatin CalciumDigoxin

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedHydrocarbonsSulfonesSulfur CompoundsPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDigitalis GlycosidesCardenolidesCardiac GlycosidesCardanolidesSteroidsFused-Ring CompoundsPolycyclic CompoundsGlycosidesCarbohydrates

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Participants cross over from reference treatment (R) to test treatment (T) (two periods, fixed sequence).
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 9, 2025

First Posted

October 10, 2025

Study Start

November 5, 2025

Primary Completion

December 7, 2025

Study Completion

December 18, 2025

Last Updated

December 22, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Locations

DE(1)