Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses of BI 639667 in Healthy Male Subjects (Single-blind, Partially Randomised, Placebo-controlled Parallel Group Design)

Boehringer Ingelheim0 sitesJuly 2014

ConditionsHealthy

InterventionsBI 639667 Placebo

DrugsPlacebo BI 639667

Overview

Phase: Phase 1
Intervention: BI 639667
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Primary Endpoint: Number of subjects with drug-related adverse events
Status: Withdrawn
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

July 2014

End Date

October 2014

Last Updated

11 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 639667

single rising doses given as oral solution

Intervention: BI 639667

Placebo

placebo solution

Intervention: Placebo

Outcomes

Primary Outcomes

Number of subjects with drug-related adverse events

Time Frame: up to 19 days postdose

Secondary Outcomes

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)