Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BI 1005273 s.c. PlaceboDrug: BI 105273 i.v. PlaceboDrug: BI 1005273 i.v.Drug: BI 1005273 s.c.
- Registration Number
- NCT01650155
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 88
Inclusion Criteria
Not provided
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Exclusion Criteria
Not provided
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description BI 1005273 s.c. Placebo BI 1005273 s.c. Placebo single dose s.c. injection (Placebo) BI 1005273 i.v. Placebo BI 105273 i.v. Placebo single dose i.v. infusion (Placebo) BI 1005273 i.v. BI 1005273 i.v. single dose i.v. infusion BI 1005273 s.c. BI 1005273 s.c. single dose s.c. injection
- Primary Outcome Measures
Name Time Method number (% subjects) with drug-related AEs. day -21 to day 95
- Secondary Outcome Measures
Name Time Method Cmax (maximum measured concentration of the analyte in plasma) day 1 to day 90 AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) day 1 to day 90 AUC0-tz (area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose) day 1 to day 90
Trial Locations
- Locations (1)
1294.1.1 Boehringer Ingelheim Investigational Site
🇩🇪Berlin, Germany