A Randomised, Double-blind, Placebo-controlled Trial in Healthy Volunteers to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of 2.5 mg to 360 mg of BI 187004 CL

Boehringer Ingelheim1 site in 1 country72 target enrollmentApril 2012

ConditionsHealthy

InterventionsBI 187004 CL Placebo to BI 187004 CL

DrugsPlacebo to BI 187004 CL BI 187004 CL

Overview

Phase: Phase 1
Intervention: BI 187004 CL
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 72
Locations: 1
Primary Endpoint: Occurrence of adverse events
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 187004 CL within a predefined dose range

Registry

clinicaltrials.gov

Start Date

April 2012

End Date

October 2012

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Boehringer Ingelheim

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

BI 187004 CL

1 single dose per subject as oral solution

Intervention: BI 187004 CL

Placebo to BI 187004 CL

1 single dose per subject as oral solution

Intervention: Placebo to BI 187004 CL

Outcomes

Primary Outcomes

Occurrence of adverse events

Time Frame: up to 15 days postdose

Secondary Outcomes

Cmax (maximum measured concentration of the analyte in plasma)(up to 96 hours postdose)
AUC0-8 (area under the concentration-time curve of the in plasma over the time interval from 0 extrapolated to infinity)(up to 96 hours postdose)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)(up to 96 hours postdose)