Single Rising Dose Study of BI 690517 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy
- Interventions
- Drug: BI 690517
- Registration Number
- NCT02891148
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising doses of BI 690517
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 50
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 690517 BI 690517 -
- Primary Outcome Measures
Name Time Method The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events. From the first drug administration until end of the trial, up to 14 days The percentage of subjects with adverse reactions, analysed as investigator defined drug-related adverse events (AEs).
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity) Pharmacokinetic blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration. Area under the concentration-time curve of the BI-690517 in plasma over the time interval from 0 extrapolated to infinity (AUC0-infinity).
Maximum measured concentration of the BI-690517 in plasma (Cmax) PK blood samples: 1:30 hours before drug administration and 30 minutes, 1, 1:30, 2, 3, 4, 6, 8, 10, 12, 14, 24, 34, 48 hours after drug administration. Maximum measured concentration of the BI-690517 in plasma (Cmax).
Trial Locations
- Locations (1)
Humanpharmakologisches Zentrum Biberach
🇩🇪Biberach, Germany