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

Pharmacokinetics and Pharmacodynamics of BI 135585 XX Administered as Oral Dose in Healthy Male Volunteers (Open-label, Single-dose Trial)

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01652742

Enrollment

Registered

2012-07-30

Start date

2012-07-31

Completion date

2012-09-30

Last updated

2013-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Brief summary

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

Interventions

DRUGBI 135585 XX

one single dose

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

1. Healthy male subjects 2. overweight or obese

Exclusion criteria

1\. Any relevant deviation from healthy conditions

Design outcomes

Primary

Measure	Time frame
Cmax (maximum measured concentration of the analyte in plasma)	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)	up to 4 days postdose

Secondary

Measure	Time frame
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)	up to 4 days postdose

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026