NCT03206632
Completed
Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 690517 in Healthy Chinese and Japanese Male Subjects (Double-blind, Randomised, Placebo-controlled Group Design)
Overview
- Phase
- Phase 1
- Intervention
- BI 690517
- Conditions
- Healthy
- Sponsor
- Boehringer Ingelheim
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Number [N (%)] of subjects with adverse reactions
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
The primary objective of this trial is to investigate the safety and tolerability of BI 690517 in healthy Chinese and Japanese male subjects following oral administration of single doses.
Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as the investigation of pharmacodynamic effects following single rising doses of BI 690517.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
BI 690517 dose group 2
Intervention: BI 690517
BI 690517 dose group 1
Intervention: BI 690517
BI 690517 dose group 3
Intervention: BI 690517
Placebo
Matching placebo for each dose group
Intervention: Placebo
Outcomes
Primary Outcomes
Number [N (%)] of subjects with adverse reactions
Time Frame: up to 336 hours
Secondary Outcomes
- AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)(up to 48 hours)
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 1
This Study Tests How Different Doses of BI 690517 Are Taken up in the Body of Healthy Men. The Study Also Looks at How Food Influences the Amount of BI 690517 in the BloodHealthyNCT03100916Boehringer Ingelheim72
Completed
Phase 1
A Study in Healthy Japanese Men to Test How Different Doses of BI 690517 Are Taken Up in the Body and How Well They Are ToleratedHealthyNCT03608072Boehringer Ingelheim36
Withdrawn
Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667HealthyNCT02133482Boehringer Ingelheim
Completed
Phase 1
Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of BI 456906 in Healthy Male VolunteersHealthyNCT03175211Boehringer Ingelheim20
Completed
Phase 1
This Study in Healthy Men Tests How Different Doses of BI 705564 Are Taken up in the Body and How Well They Are Tolerated. The Study Also Tests How BI 705564 Affects the Way the Body Breaks Down MidazolamHealthyNCT03325712Boehringer Ingelheim60