Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses of BI 163538 XX

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo to BI 163538 XX; Drug: BI 163538 XX

• Registration Number: NCT01587391
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate safety, tolerability, pharmacokinetics including dose proportionality, and pharmacodynamics of BI 163538 XX within a predefined dose range

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-04-30
• Primary Completion: 2012-10
• Study Completion: 2012-10
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-30
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 48

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo to BI 163538 XX	Placebo to BI 163538 XX	1 single dose per subject as oral solution
BI 163538 XX	BI 163538 XX	1 single dose per subject as oral solution

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	up to 15 days postdose

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

1291.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Neuss, Germany