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

Boehringer Ingelheim48 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Healthy

Interventions

Placebo to BI 163538 XXDRUG

1 single dose per subject as oral solution

BI 163538 XXDRUG

1 single dose per subject as oral solution

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)

1291.1.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Outcomes

Primary Outcomes

Occurrence of adverse events

Time frame: up to 15 days postdose

Secondary Outcomes

Cmax (maximum measured concentration of the analyte in plasma)

Time frame: up to 96 hours postdose

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

Time frame: 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)

Time frame: up to 96 hours postdose

Data from ClinicalTrials.gov

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