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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1358894

• Registration Number: NCT04426851
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Study Start: 2020-07-13
• Status Verified: 2020-10
• Primary Completion: 2020-10-12
• Study Completion: 2020-10-12
• Last Update Submitted: 2020-10-28
• Last Update Posted: 2020-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 12

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Part 1: BI 1358894 (Test 1-Reference 1)	BI 1358894	BI 1358894
Part 2: BI 1358894 (Test 2-Reference 2)	BI 1358894	BI 1358894
Part 2: BI 1358894 (Reference 2-Test 2)	BI 1358894	BI 1358894

Primary Outcome Measures

Name	Time	Method
Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after intravenous (iv) administration) for (C-14) BI 1358894 iv	Up to 14 days
Part 1: AUC 0-inf (area under the concentration-time curve of the analyte over the time interval from 0 to infinity after oral (po) administration) for BI 1358894 po	Up to 14 days
Part 2: AUC 0-312 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 312 h)	Up to 14 days

Secondary Outcome Measures

Name	Time	Method
Part 2: Cmax (maximum measured concentration of the analyte after oral administration)	Up to 14 days
Part 2: AUC 0-inf (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity after oral administration)	Up to 14 days
Part 1: Cmax (maximum measured concentration of the analyte after oral administration)	Up to 14 days

Trial Locations

Locations (1)

PRA Health Sciences Onderzoekscentrum Martini; 🇳🇱 Groningen, Netherlands