NCT01652742

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jul 2012

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

July 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 7, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

July 26, 2012

Last Update Submit

March 6, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • 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

Study Arms (1)

BI 135585 XX

EXPERIMENTAL

one single dose

Drug: BI 135585 XX

Interventions

BI 135585 XXDRUG

one single dose

BI 135585 XX

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male subjects
  • overweight or obese

You may not qualify if:

  • \. Any relevant deviation from healthy conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1283.34.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2012

First Posted

July 30, 2012

Study Start

July 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 7, 2013

Record last verified: 2013-03

Locations

DE(1)