A Study in Healthy Men to Test How BI 1358894 is Taken up in the Body and How Food Influences the Amount of BI 1358894 in the Blood

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: BI 1358894 (C-14) intravenous solution; Drug: BI 1358894

Study type: Interventional

Funder types: Industry

Identifiers

NCT04426851

2020-000351-13 (EudraCT Number)

1402-0016

Details and patient eligibility

About

The main objective of Part 1 of this trial is to investigate the absolute bioavailability of BI 1358894 with an intravenous microdose formulation containing labelled [C-14] BI 1358894 and an unlabelled oral tablet formulation of BI 1358894 in healthy male subjects.

The main objective of Part 2 of this trial is to investigate the relative bioavailability of BI 1358894 administered as an oral suspension.

Enrollment: 12 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy male subjects according to the assessment of the investigator, as based on a complete medical history including a physical examination, vital signs (BP, PR), 12-lead ECG, and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• 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
• Male subjects who meet any of the following criteria from at least 30 days before the first administration of trial medication until 90 days after trial completion:
• Use of adequate contraception of the female partner, e.g. any of the following methods plus condom: implants, injectables, combined oral or vaginal contraceptives, intrauterine device that started at least 2 months prior to first study drug administration or barrier method (e.g. diaphragm with spermicide) or,
• Sexually abstinent or
• A vasectomy performed at least 1 year prior to screening (with medical assessment of the surgical success) or
• Surgically sterilised female partner (including hysterectomy, bilateral tubal occlusion or bilateral oophorectomy) or
• Postmenopausal female partner, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with FSH (follicle stimulating hormone) 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 40 to 100 bpm
• C-reactive protein (CRP) > upper limit of normal (ULN), liver or kidney parameter above ULN
• 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
• Further exclusion criteria apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

BI 1358894: Part 1: tablet (T1) - (C14) i.v (R1), Part 2: fasted (R2) - fed (T2)

Experimental group

Description:

BI 1358894

Treatment:

Drug: BI 1358894

Drug: BI 1358894 (C-14) intravenous solution

Drug: BI 1358894

BI 1358894: Part 1: tablet (T1) - (C14) i.v (R1), Part 2: fed (T2) - fasted (R2)

Experimental group

Description:

BI 1358894

Treatment:

Drug: BI 1358894

Drug: BI 1358894 (C-14) intravenous solution

Drug: BI 1358894