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 160 mg of BI 163538 XX

Boehringer Ingelheim1 site in 1 country48 target enrollmentApril 2012

ConditionsHealthy

InterventionsBI 163538 XX Placebo to BI 163538 XX

DrugsPlacebo to BI 163538 XX BI 163538 XX

Overview

Phase: Phase 1
Intervention: BI 163538 XX
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Enrollment: 48
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 163538 XX 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 163538 XX

1 single dose per subject as oral solution

Intervention: BI 163538 XX

Placebo to BI 163538 XX

1 single dose per subject as oral solution

Intervention: Placebo to BI 163538 XX

Outcomes

Primary Outcomes

Occurrence of adverse events

Time Frame: up to 15 days postdose

Secondary Outcomes

AUC0-∞ (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)
Cmax (maximum measured concentration of the analyte in plasma)(up to 96 hours postdose)