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

NCT05863130 | Completed Phase 1

• 1 other identifier: 1434-0016
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (2)

BI 764198 (C-14) (approach 1)

EXPERIMENTAL

Drug: BI 764198 (C-14) (approach 1)

BI 764198 (C-14) (approach 2)

EXPERIMENTAL

Drug: BI 764198 (C-14) (approach 2)

Interventions

BI 764198 (C-14) (approach 1) DRUG

BI 764198 (C-14) (approach 1)

BI 764198 (C-14) (approach 1)

BI 764198 (C-14) (approach 2) DRUG

BI 764198 (C-14) (approach 2)

BI 764198 (C-14) (approach 2)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

ICON

Groningen, 9728 NZ, Netherlands

Location

Related Links

• Related Info

MeSH Terms

Interventions

Carbon-14

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2023
• First Posted: May 17, 2023
• Study Start: May 3, 2023
• Primary Completion: November 9, 2023
• Study Completion: November 9, 2023
• Last Updated: November 15, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)