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

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1358894, Trial Formulation 2 (TFII) (R); Drug: BI 1358894, intended Commercial Formulation (iCF) (T)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05155306

2021-004880-28 (EudraCT Number)

1402-0020

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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
• History of relevant orthostatic hypotension, fainting spells, or blackouts Further exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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24 participants in 4 patient groups

BI 1358894 - test - fasted

Experimental group

Description:

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.

Treatment:

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

BI 1358894 - test - fed

Experimental group

Description:

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.

Treatment:

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

BI 1358894 - reference - fasted

Experimental group

Description:

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.

Treatment:

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

BI 1358894 - reference - fed

Experimental group

Description:

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.

Treatment:

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