A Study in Healthy Men to Find Out How BI 1015550 is Taken up and Handled by the Body

Healthy Clinical Trial

Official title:

A Phase I, Open-label, Non-randomized, Single-dose, Single-arm, Single-period Study to Investigate the Metabolism and Pharmacokinetics of [C-14]-Labelled BI 1015550 After Oral Administration in Healthy Male Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04771286
• Other study ID #: 1305-0016
• Secondary ID: 2020-005934-13
• Status: Completed
• Phase: Phase 1
• Start date: March 25, 2021
• Est. completion date: May 17, 2021

Study information

• Verified date: May 2021
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 1015550 and its metabolite BI 764333 (M480), [14C]-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose BI 1015550 (C-14) administered to healthy male subjects.

The primary objective is:

• To assess the mass balance recovery of [14C]-radioactivity from urine and faeces as well as vomit in case of occurrence after a single oral dose of BI 1015550 (C-14) administered to healthy male subjects

The secondary objectives are:

• To assess the pharmacokinetics of [C-14]-BI 1015550 and BI 1015550 as well as its metabolite BI 764333 in plasma following a single oral dose of BI 1015550 (C-14)

• To assess the safety and tolerability of BI 1015550

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: May 17, 2021
• Est. primary completion date: May 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 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 (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiograms (ECG), and clinical laboratory tests

• Age of 18 to 65 years (inclusive)

• Body mass index (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 Good Clinical Practice (GCP) and local legislation

• Male subjects who meet any of the following criteria from screening 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, which started at least two 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 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 blood pressure (BP), pulse rate (PR) or electrocardiogram (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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 (beats per minute) 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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BI 1015550 (C-14)
BI 1015550 (C-14)

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	Amount of [14C]-radioactivity excreted as a percentage of the administered single oral dose of BI 1015550 (C-14) in urine (feurine, 0-t2) and faeces (fefaeces, 0-t2) as well as vomit (fevomit, 0-t2), if applicable		up to day 31
Secondary	Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)		up to day 10
Secondary	Maximum measured concentration of the analyte in plasma (Cmax)		up to day 10

External Links

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