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To Assess Safety, Tolerability and Pharmacokinetics of BI 416970 in Healthy Male Volunteers

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo to BI 416970
Drug: BI 416970
Registration Number
NCT02093819
Lead Sponsor
Boehringer Ingelheim
Brief Summary

To investigate the safety and tolerability of BI 416970 and to assess the pharmacokinetics (PK) of single rising doses of BI 416970. A further objective is to assess the influence of CYP2C9 phenotype on the PK of BI 416970.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
60
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
BI 416970 single rising dose partPlacebo to BI 416970single rising dose given as tablet
BI 416970 single rising dose partBI 416970single rising dose given as tablet
Primary Outcome Measures
NameTimeMethod
Percentage of Subjects With Drug-related Adverse EventsAEs were recorded throughout the trial

Percentage of subjects with drug-related adverse events

Secondary Outcome Measures
NameTimeMethod
Cmax (Maximum Measured Concentration of the Analyte in Plasma)2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration

Cmax (maximum measured concentration of the analyte in plasma)

AUC 0-infinity (Area Under the Concentration-time Curve of the Analyte in Plasma Over the Time Interval From 0 Extrapolated to Infinity)2 hour (h) before drug administration and 15minutes (min), 30min, 45min, 1h,1h 30min, 1h 45min, 2h, 3h, 4h, 4h 15min, 6h, 7h, 8h, 10h, 12h, 24h, 34h and 48h after drug administration

AUC 0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Trial Locations

Locations (1)

1345.1.1 Boehringer Ingelheim Investigational Site

🇩🇪

Biberach, Germany

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