Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667

Phase 1

Withdrawn

• Conditions: Healthy
• Interventions: Drug: BI 639667; Drug: Placebo

• Registration Number: NCT02133482
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is to investigate the safety and tolerability of BI 639667 in healthy male subjects following oral administration of single rising doses.

Secondary objectives are the exploration of the pharmacokinetics (PK) including dose proportionality as well as investigation of linearity and pharmacodynamics (PD) of BI 639667 after single dosing and the assessment of the PK/PD relationship.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-07
• Study First Submitted QC: 2014-05-07
• Study First Posted: 2014-05-08
• Status Verified: 2014-07
• Study Start: 2014-07
• Last Update Submitted: 2014-07-14
• Last Update Posted: 2014-07-15
• Primary Completion: 2014-10
• Study Completion: 2014-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: Not specified

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 639667	BI 639667	single rising doses given as oral solution
Placebo	Placebo	placebo solution

Primary Outcome Measures

Name	Time	Method
Number of subjects with drug-related adverse events	up to 19 days postdose

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)	up to 120 hours postdose
Cmax (maximum measured concentration of the analyte in plasma)	up to 120 hours postdose