A Phase I Trial to Investigate the Metabolism and Pharmacokinetics of an Open-label Single Dose of 400 mg [14C]BI 671800 HEA Administered as an Oral Solution of the Choline Salt in Healthy Male Volunteers.
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces
Study Overview
Brief Summary
The main objectives of the present study are to investigate the basic pharmacokinetics of BI 671800, its major metabolite CD6384, and 14C-radioactivity, including mass balance, excretion pathways and metabolism following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers. Secondary objectives are to evaluate the safety and tolerability following a single oral dose of 400 mg [14C]BI 671800 HEA to healthy male volunteers.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 671800 high dose
Oral drinking solution
Intervention: BI 671800 (Drug)
Outcomes
Primary Outcomes
Individual time course profiles of 14C-radioactivity (in nmol eq/L or nmol eq/kg for faeces) in whole blood, plasma, urine, and faeces
Time Frame: up to 336 h post treatment
Individual time course profiles of BI 671800 and its major metabolite CD6384 in plasma and urine
Time Frame: up to 336 h post treatment
concentrations of 14C-radioactivity in whole blood, plasma, urine, and faeces
Time Frame: up to 336 h post treatment
Rate and extent of excretion mass balance based on the total radioactivity in urine and faeces
Time Frame: up to 336 h post treatment
Cblood cells/Cplasma ratio of 14C-radioactivity
Time Frame: up to 168 h post treatment
concentrations of BI 671800 and its metabolite CD6384 in plasma and urine
Time Frame: up to 336 h post treatment
Elucidation of metabolite structures and identification of major metabolites in plasma, urine, and faeces (if feasible) in comparison with various animal species (to be presented in a separate report)
Time Frame: up to 336 h post treatment
Secondary Outcomes
- Changes from Baseline in Vital signs (pulse rate)(up to 23 days post treatment)
- Changes from Baseline in Physical examination(up to 23 days post treatment)
- Changes from Baseline in Vital signs (blood pressure)(up to 23 days post treatment)
- Assessment of tolerability by investigator(up to 23 days post treatment)
- Changes from Baseline in 12-lead electrocardiogram (ECG)(up to 23 days post treatment)
- Changes from Baseline in Clinical laboratory tests(up to 23 days post treatment)
- Occurrence of Adverse Events(up to 23 days post treatment)