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

NCT ID: NCT07215260

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2025-12-18

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

CROSSOVER

Participants cross over from reference treatment (R) to test treatment (T) (two periods, fixed sequence).
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Cocktail consisting of rosuvastatin and digoxin.

Group Type EXPERIMENTAL

BI 3000202

Intervention Type DRUG

BI 3000202

Rosuvastatin

Intervention Type DRUG

Rosuvastatin

Digoxin

Intervention Type DRUG

Digoxin

Interventions

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BI 3000202

BI 3000202

Intervention Type DRUG

Rosuvastatin

Rosuvastatin

Intervention Type DRUG

Digoxin

Digoxin

Intervention Type DRUG

Other Intervention Names

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CRESTOR® Lanicor®

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Humanpharmakologisches Zentrum Biberach

Biberach, , Germany

Site Status

Countries

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Germany

Related Links

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http://www.mystudywindow.com

Related Info

Other Identifiers

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2025-520656-29-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1317-7517

Identifier Type: REGISTRY

Identifier Source: secondary_id

1509-0014

Identifier Type: -

Identifier Source: org_study_id