Investigation of Single Rising Doses of BI 685509

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 685509; Drug: Placebo

• Registration Number: NCT02694354
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety, tolerability, pharmacokinetics and pharmacodynamics following single rising oral doses of BI 685509

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-02-25
• Study First Submitted QC: 2016-02-25
• Study First Posted: 2016-02-29
• Study Start: 2016-03
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-03
• Last Update Posted: 2016-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 16

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

Group	Intervention	Description
BI 685509	BI 685509	-
Placebo	Placebo	matching placebo

Primary Outcome Measures

Name	Time	Method
Number [N(%)] of the subject with drug-related Adverse Events	0-48 hours

Secondary Outcome Measures

Name	Time	Method
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	0-24 hours
Cmax (maximum concentration of the analyte in plasma)	0-24 hours

Trial Locations

Locations (1)

1366.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Biberach, Germany