Safety, Tolerability, Pharmacokinetics of Single Rising Oral Doses of BI 1181181 in Healthy Male Volunteers, Including Investigation of the Effect of Food on the Bioavailability of BI 1181181

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: BI 1181181, R; Drug: BI 1181181; Drug: BI 1181181, T2; Drug: Placebo to BI 1181181; Drug: BI 1181181, T1

• Registration Number: NCT02044406
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-22
• Study First Submitted QC: 2014-01-22
• Study First Posted: 2014-01-24
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 65

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
2 BI 1181181 bioavailability part	BI 1181181, T2	bioavailability, food effect part of BI 11881181
2 BI 1181181 bioavailability part	BI 1181181, T1	bioavailability, food effect part of BI 11881181
2 BI 1181181 bioavailability part	BI 1181181, R	bioavailability, food effect part of BI 11881181
1 BI 1181181 single rising dose part	BI 1181181	single rising doses of BI 1181181
1 BI 1181181 single rising dose part	Placebo to BI 1181181	single rising doses of BI 1181181

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 h
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point)	up to 72 h
Number (%) of subjects with drug-related adverse events (AEs)	up to 72 h

Secondary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	up to 72 h
t1/2 (terminal half-life of the analyte in plasma)	up to 72 h
Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)	up to 72 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)	up to 72 h
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	up to 72 h

Trial Locations

Locations (1)

1344.1.1 Boehringer Ingelheim Investigational Site; 🇩🇪 Ingelheim, Germany