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A Study in Healthy People to Compare 2 Different Formulations of BI 1358894 Tablets Taken With or Without Food

NCT ID: NCT05155306

Last Updated: 2025-02-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-14

Study Completion Date

2022-05-16

Brief Summary

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To investigate the relative bioavailability of the intended Commercial Formulation (iCF) (Test, T) compared with Trial Formulation 2 (TFII) (Reference, R) and to assess potential food effects following oral administration of BI 1358894.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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BI 1358894 - test - fasted

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

BI 1358894, intended Commercial Formulation (iCF) (T)

Intervention Type DRUG

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning

BI 1358894 - test - fed

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning following a high-fat, high-calorie meal.

Group Type EXPERIMENTAL

BI 1358894, intended Commercial Formulation (iCF) (T)

Intervention Type DRUG

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning

BI 1358894 - reference - fasted

A single dose of 100 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following an overnight fast of at least 10 hours.

Group Type EXPERIMENTAL

BI 1358894, Trial Formulation 2 (TFII) (R)

Intervention Type DRUG

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.

BI 1358894 - reference - fed

A single dose of 00 mg (milligram) BI 1358894 given orally as two 50 mg film-coated tablets in the morning following a high-fat, high-calorie meal.

Group Type EXPERIMENTAL

BI 1358894, Trial Formulation 2 (TFII) (R)

Intervention Type DRUG

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.

Interventions

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BI 1358894, intended Commercial Formulation (iCF) (T)

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning

Intervention Type DRUG

BI 1358894, Trial Formulation 2 (TFII) (R)

A single dose of 100 mg (milligram) BI 1358894 given orally as a film-coated tablet in the morning.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female 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/m\^2 (inclusive)
* Signed and dated written informed consent in accordance with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
* Either male subject, or female subject who meet any of the following criteria for a highly effective contraception from at least 30 days before administration of trial medication until 30 days after trial completion:

* Use of combined (estrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus one additional barrier
* Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus one additional barrier
* Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS), plus one additional barrier
* Sexually abstinent
* A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant plus one additional barrier
* Bilateral tubal ligation plus one additional barrier
* Surgically sterilised (including hysterectomy, bilateral salpingectomy, bilateral oophorectomy)
* Postmenopausal, defined as no menses for 1 year without an alternative medical cause (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 that could interfere with the pharmacokinetics of the trial medication (except appendectomy or simple hernia repair)
* 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

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

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://www.mystudywindow.com

Related Info

Other Identifiers

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2021-004880-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1402-0020

Identifier Type: -

Identifier Source: org_study_id

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