A Study in Healthy Men to Test How BI 764198 is Processed in the Body

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 764198 (C-14) (approach 2); Drug: BI 764198 (C-14) (approach 1)

• Registration Number: NCT05863130
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198 and its metabolites, total radioactivity including mass balance, excretion pathways and metabolism following oral administration to healthy male volunteers of a single oral dose of BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-04-25
• Study Start: 2023-05-03
• Study First Submitted QC: 2023-05-08
• Study First Posted: 2023-05-17
• Status Verified: 2023-11
• Primary Completion: 2023-11-09
• Study Completion: 2023-11-09
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 24

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 65 years (inclusive)
• BMI of 18.5 to 29.9 kg/m2 (inclusive)
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial

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 45 to 90 mmHg, or pulse rate outside the range of 40 to 100 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 Further exclusion criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BI 764198 (C-14) (approach 2)	BI 764198 (C-14) (approach 2)	-
BI 764198 (C-14) (approach 1)	BI 764198 (C-14) (approach 1)	-

Primary Outcome Measures

Name	Time	Method
Fraction of [14C]-radioactivity excreted in urine expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (feurine,0-tz)	Up to 31 days
Fraction of [14C]-radioactivity excreted in faeces expressed as percentage of the administered dose over the time interval from 0 to the last quantifiable time point (fefaeces,0-tz)	Up to 31 days

Secondary Outcome Measures

Name	Time	Method
Maximum measured concentration of the analyte in plasma (Cmax)	Up to 31 days
Area under the concentration-time curve of the analyte over the time interval from 0 to the last quantifiable data point) in plasma (AUC0-tz)	Up to 31 days

Trial Locations

Locations (1)

ICON; 🇳🇱 Groningen, Netherlands