Study to Explore Pharmacokinetics and Pharmacodynamics of a Single Rising Dose of BI 135585 XX

Phase 1CompletedNCT01652742

Boehringer Ingelheim9 enrolled

Overview

To investigate the pharmacokinetics and pharmacodynamics of BI 135585 XX following single dose administration.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

BI 135585 XXDRUG

one single dose

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion criteria: 1. Healthy male subjects 2. overweight or obese Exclusion criteria: 1\. Any relevant deviation from healthy conditions

Locations (1)

1283.34.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Outcomes

Primary Outcomes

Cmax (maximum measured concentration of the analyte in plasma)

Time frame: up to 4 days 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)

Time frame: up to 4 days postdose

Secondary Outcomes

AUC0-8 of BI 135585 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

Time frame: up to 4 days postdose

Data from ClinicalTrials.gov

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