At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled / 24 target
Drug / intervention
BI 764198 (C-14) (approach 1) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I, Open-label, Two-arm, Non-randomised Trial to Investigate the Metabolism and Pharmacokinetics of a Single Dose of BI 764198 (C-14) Administered as Oral Solution Using Two Different Approaches in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 764198 (C-14) (approach 1) and BI 764198 (C-14) (approach 2) for Healthy. Completed, enrolled 24 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
202420252026
Enrollment StartMay 2023
First PostedMay 2023
Primary CompletionNov 2023
TodayJul 2026
First PostedMay 17, 2023
Enrollment StartMay 3, 2023
Primary CompletionNov 9, 2023
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 3.1 years ago
Arms & Interventions
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 2)drug
BI 764198 (C-14) (approach 2)