A Study in Healthy People to Test Whether BI 730357 Influences the Amount of Caffeine, Warfarin, Omeprazole, and Midazolam in the Blood

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-21

Study Completion Date

2021-03-17

Brief Summary

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The trial will be performed to assess the influence of BI 730357 on the pharmacokinetics of caffeine, warfarin, omeprazole and midazolam.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Two Periods (Period 1 and Period 2) for each participant.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cocktail/ Cocktail + BI 730357

Cocktail treatment will be followed by the Test treatment (Cocktail + BI 730357) in a fixed sequence. The treatment periods are separated by a wash-out phase of at least 20 days between the two cocktail administrations.

Group Type EXPERIMENTAL

Percoffedrinol®

Intervention Type DRUG

Tablet

Coumadin®

Intervention Type DRUG

Tablet

Antra MUPS®

Intervention Type DRUG

Gastro-resistant tablet

Midazolam-ratiopharm®

Intervention Type DRUG

Oral solution

BI 730357

Intervention Type DRUG

Film-coated tablet

Interventions

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Percoffedrinol®

Tablet

Intervention Type DRUG

Coumadin®

Tablet

Intervention Type DRUG

Antra MUPS®

Gastro-resistant tablet

Intervention Type DRUG

Midazolam-ratiopharm®

Oral solution

Intervention Type DRUG

BI 730357

Film-coated tablet

Intervention Type DRUG

Other Intervention Names

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Caffeine Warfarin sodium Omeprazole Midazolam

Eligibility Criteria

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Inclusion Criteria

* Healthy subjects 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/m2 (inclusive)
* Signed and dated written informed consent prior to admission to the study, in accordance with GCP and local legislation
* Either male subject, or female subject who meet any of the following criteria from at least 30 days before the first administration of trial medication until 30 days after trial completion:

* Use of non-hormonal intrauterine device plus condom for birth control
* A vasectomised sexual partner (vasectomy at least 1 year prior to enrolment)
* Surgically sterilised (including hysterectomy or bilateral tubal occlusion)
* Postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with levels of follicle stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory)

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 mmHg, diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 45 to 90 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
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, or hormonal disorders
* Cholecystectomy or other surgery of the gastrointestinal tract (except appendectomy or simple hernia repair) that could interfere with the pharmacokinetics (PK) of the trial medication
* Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes