NCT01587391

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Apr 2012

Typical duration 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

April 1, 2012

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
Last Updated

October 31, 2013

Status Verified

October 1, 2013

Enrollment Period

6 months

First QC Date

April 26, 2012

Last Update Submit

October 30, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Occurrence of adverse events

    up to 15 days postdose

Secondary Outcomes (3)

  • Cmax (maximum measured concentration of the analyte in plasma)

    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)

    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)

    up to 96 hours postdose

Study Arms (2)

BI 163538 XX

EXPERIMENTAL

1 single dose per subject as oral solution

Drug: BI 163538 XX

Placebo to BI 163538 XX

PLACEBO COMPARATOR

1 single dose per subject as oral solution

Drug: Placebo to BI 163538 XX

Interventions

Placebo to BI 163538 XXDRUG

1 single dose per subject as oral solution

Placebo to BI 163538 XX
BI 163538 XXDRUG

1 single dose per subject as oral solution

BI 163538 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)

1291.1.1 Boehringer Ingelheim Investigational Site

Neuss, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 26, 2012

First Posted

April 30, 2012

Study Start

April 1, 2012

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

October 31, 2013

Record last verified: 2013-10

Locations

DE(1)