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

NCT05863130 | Completed Phase 1 Results

• 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 (1)

• Mass Balance Recovery of Total Radioactivity in Urine and Faeces: Amount Excreted Within the Time Interval From 0 to the Time of the Last Quantifiable Data Point as a Percentage of the Administered Dose (fe0-tz) for Urine and Faeces.

  Urine: Within 2 hours before drug administration, and at 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. Feces: up to 48 hours (feces) before drug administration, and at 24, 48, 72, 96, 120, 144, 168, and 192 hours post-drug administration. If warranted, further 24-hour collections at trial site were performed at 365-389, 533-557-, and 701-725-hours post-administration depending on participants fulfilling the radioactivity recovery criteria.

  Urine and feces sample collection: 48 hours before and up to 725 hours after drug administration. The details are mentioned in the description section.

Secondary Outcomes (4)

• AUC0-tz, Area Under the Concentration-time Curve of [14C]-BI 764198-EQ Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198.

  Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.

• AUC0-tz, Area Under the Concentration-time Curve of BI 764198 Over the Time Interval From 0 to the Last Quantifiable Time Point in Plasma After Single Oral Administration of [14C]BI 764198.

  Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.

• Cmax, Maximum Measured Concentration of [14C]-BI 764198-EQ in Plasma After Single Oral Administration of [14C]BI 76418.

  Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.

• Cmax, Maximum Measured Concentration of BI 76418 in Plasma After Single Oral Administration of [14C]BI 76418.

  Within 3 hours before drug intake, and at 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 365, 533, and 701 hours post-administration.

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

Limitations and Caveats

An additional cohort (2b) was introduced due to errors in plasma samples from the first 8 participants in cohort 2a, preventing reliable metabolite profiling. Cohort 2b received the same treatment to enable proper profiling. The assessment schedule for cohort 2b was abbreviated, release criteria were not applied, and data from cohorts 2a and 2b were pooled for analysis.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

018002430127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

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: June 29, 2026
• Results First Posted: June 3, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)