At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
BI 730357 mixed with [C-14]BI 730357 BSdrug
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, Single-dose Trial to Investigate Metabolism and Pharmacokinetics of BI 730357 BS (C-14) Administered as Oral Solution in Healthy Male Volunteers
In Brief
A Phase 1 clinical trial evaluating BI 730357 mixed with [C-14]BI 730357 BS for Healthy. Completed, enrolled 6 participants across 1 site.
Detailed Summary
The main objectives of the study are as follows: * To assess the mass balance recovery of (C-14) BI 730357-radioactivity (also expressed as 14C-BI 730357-EQ) in urine and faeces after a single oral dose of 50 mg BI 730357 base (BS) (C-14) in healthy male subjects * To provide plasma, urine, and faecal samples for metabolite profiling and structural identification
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesNetherlands
Collaborators--
Timeline
Phase 1CompletedFinished
20192020202120222023202420252026
First PostedSep 2018
Enrollment StartSep 2018
Primary CompletionNov 2018
TodayJul 2026
First PostedSep 10, 2018
Enrollment StartSep 10, 2018
Primary CompletionNov 13, 2018
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 7.8 years ago
Interventions
BI 730357 mixed with [C-14]BI 730357 BSdrug
Oral Solution