Phase 1
N=24
A Study in Healthy Men to Test How BI 764198 is Processed in the Body
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT05863130 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2026
Primary outcome: Primary: 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. — 73.7; 73.2; 22.9; 22.4 Percentage of dose excreted
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BI 764198 (C-14) (approach 1) (Drug); BI 764198 (C-14) (approach 2) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- Boehringer Ingelheim
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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. |
73.7; 73.2; 22.9; 22.4 | — |
| SECONDARY 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. |
27500; 37600 | — |
| SECONDARY 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. |
13200; 14500 | — |
| SECONDARY Cmax, Maximum Measured Concentration of [14C]-BI 764198-EQ in Plasma After Single Oral Administration of [14C]BI 76418. |
1740; 1800 | — |
| SECONDARY Cmax, Maximum Measured Concentration of BI 76418 in Plasma After Single Oral Administration of [14C]BI 76418. |
1420; 1450 | — |
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.
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 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
Data sourced from ClinicalTrials.gov (NCT05863130). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.