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

Healthy Clinical Trial

Official title:

Investigation of Pharmacokinetics and Absolute Bioavailability of BI 1358894 Administered Orally as Tablet Co-administered With an Intravenous Microtracer Dose of [C-14]-BI 1358894 in Healthy Male Volunteers Via a Non-randomised, Open-label, Fixed-sequence Trial (Part 1) Followed by a Randomised, Open-label, Single-dose, Two-period, Two-sequence Cross-over Relative Bioavailability Trial in BI 1358894 Oral Suspension (Part 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426851
• Other study ID #: 1402-0016
• Secondary ID: 2020-000351-13
• Status: Completed
• Phase: Phase 1
• Start date: July 13, 2020
• Est. completion date: October 12, 2020

Study information

• Verified date: October 2020
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 12, 2020
• Est. primary completion date: October 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1358894
BI 1358894

Locations

Country	Name	City	State
Netherlands	PRA Health Sciences Onderzoekscentrum Martini	Groningen

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Part 1: Cmax (maximum measured concentration of the analyte after oral administration)		Up to 14 days
Secondary	Part 2: Cmax (maximum measured concentration of the analyte after oral administration)		Up to 14 days
Secondary	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