A Study in Healthy Men to Test How BI 685509 is Processed in the Body

NCT ID: NCT05515328

Last Updated: 2022-11-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-08
• Study Completion Date: 2022-11-17

Brief Summary

The main objective of Part A is to investigate basic pharmacokinetics of BI 685509 and total radioactivity, including mass balance, excretion pathways and metabolism following administration of BI 685509 to healthy male subjects.

The main objective of Part B is to determine the absolute bioavailability of BI 685509 after administration to healthy male subjects.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Part A: Arm 1

Group Type: EXPERIMENTAL

[¹⁴C] BI 685509 formulation 1

Intervention Type: DRUG

\[¹⁴C\] BI 685509 formulation 1

Part B: Arm 1 - Reference

Group Type: EXPERIMENTAL

[¹⁴C] BI 685509 formulation 2

Intervention Type: DRUG

\[¹⁴C\] BI 685509 formulation 2

Part B: Arm 2 - Treatment

Group Type: EXPERIMENTAL

BI 685509 formulation 3

Intervention Type: DRUG

BI 685509 formulation 3

Interventions

[¹⁴C] BI 685509 formulation 1

\[¹⁴C\] BI 685509 formulation 1

Intervention Type: DRUG

[¹⁴C] BI 685509 formulation 2

\[¹⁴C\] BI 685509 formulation 2

Intervention Type: DRUG

BI 685509 formulation 3

BI 685509 formulation 3

Intervention Type: DRUG

Eligibility Criteria

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 Electrocardiogram (ECG), and clinical laboratory tests
• Age of 18 to 55 years (inclusive)
• Body mass index (BMI) of 18.5 to 29.9 weight divided by height squared (kg/m2) (inclusive)
• Signed and dated written informed consent in accordance with International Council on Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial
• Male subjects with women of child-bearing potential (WOCBP) partner who are vasectomised or willing to use male contraception (condom or sexual abstinence) from time point of study drug administration until 15 weeks thereafter

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 millimetre of mercury (mmHg), diastolic blood pressure outside the range of 50 to 90 mmHg, or pulse rate outside the range of 40 to 90 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Boehringer Ingelheim

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ICON

Groningen, , Netherlands

Countries

Netherlands

Related Links

http://www.mystudywindow.com

Related Info

Other Identifiers

2022-001549-19

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1366-0008

Identifier Type: -

Identifier Source: org_study_id