NCT01189175

Brief Summary

The objective of the study is to investigate whether ketoconazole affects plasma exposure of BI 113823

Trial Health

80
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below 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

August 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

August 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 26, 2010

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

1 month

First QC Date

August 25, 2010

Last Update Submit

October 31, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • AUC0-∞(area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) of BI 113823

    2 weeks

  • Cmax (maximum measured concentration of the analyte in plasma) of BI 113823

    2 weeks

Secondary Outcomes (18)

  • 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)

    2 weeks

  • Number of participants with clinically significant changes in physical examination

    up to 24 days

  • Number of participants with clinically significant changes in vital signs

    up to 24 days

  • Number of participants with clinically significant changes in ECG

    up to 24 days

  • Number of participants with clinically significant changes in laboratory tests

    up to 24 days

  • +13 more secondary outcomes

Study Arms (2)

BI 113823

EXPERIMENTAL

single oral dose per subject

Drug: BI 113823

BI 113823 + Ketokonazole

EXPERIMENTAL

after wash-out 5 days ketokonazole with BI 113823 on day 3

Drug: BI 113823 + Ketokonazole

Interventions

BI 113823 + KetokonazoleDRUG

5 days ketokonazole with single oral dose of BI 113823 on day 3

BI 113823 + Ketokonazole
BI 113823DRUG

single oral dose

BI 113823

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy male subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1272.5.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 25, 2010

First Posted

August 26, 2010

Study Start

August 1, 2010

Primary Completion

September 1, 2010

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

DE(1)