NCT01291732
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)
ConditionsHealthy
Overview
- Phase
- Phase 1
- Intervention
- BI 135585 XX
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 48
- Locations
- 1
- Primary Endpoint
- Occurrence of Adverse events
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 135585 XX
single dose of BI 135585
Intervention: BI 135585 XX
matching placebo
single dose of matching placebo
Intervention: Matching placebo
Outcomes
Primary Outcomes
Occurrence of Adverse events
Time Frame: up to 21 days
Changes in 12-lead ECG (electrocardiogram)
Time Frame: up to 21 days
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
Time Frame: up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
Time Frame: up to 21 days
Secondary Outcomes
- Tmax (maximum measured concentration of the analyte in plasma)(10 days)
- AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(10 days)
- Cmax (maximum measured concentration of the analyte in plasma)(10 days)
Study Sites (1)
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