NCT01897597

Brief Summary

The purpose of this trial is to investigate the relative bioavailability of a BI 144807 tablet formulation compared to the oral solution formulation after single dose administration (intermediate and high dose) under fasted conditions. Further objectives are to assess whether and to what extent food affects single dose pharmacokinetics of BI 144807 administered as tablet, and to compare the relative bioavailability of two different tablet formulations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
31

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Jul 2013

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, 2013

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 12, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

September 6, 2013

Status Verified

September 1, 2013

Enrollment Period

2 months

First QC Date

July 9, 2013

Last Update Submit

September 4, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)

    48 hours

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

    48 hours

Secondary Outcomes (1)

  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)

    48 hours

Study Arms (7)

BI 144807 PfoS Treatment A

EXPERIMENTAL

intermediate dose of BI 144807

Drug: BI 144807 intermediate dose

BI 144807 PfoS Treatment C

EXPERIMENTAL

high dose of BI 144807

Drug: BI 144807 high dose

BI 144807 Tab Treatment B

EXPERIMENTAL

intermediate dose of BI 144807

Drug: BI 144807 intermediate dose

BI 144807 Tab Treatment D

EXPERIMENTAL

high dose of BI 144807

Drug: BI 144807 high dose

BI 144807 Tab Treatment E

EXPERIMENTAL

intermediate dose of BI 144807, fasted

Drug: BI 144807 intermediate dose

BI 144807 Tab Treatment F

EXPERIMENTAL

intermediate dose of BI 144807, fed

Drug: BI 144807 intermediate dose

BI 144807 Tab Treatment G

EXPERIMENTAL

intermediate dose of BI 144807, fasted

Drug: BI 144807 intermediate dose

Interventions

BI 144807 high doseDRUG

oral solution

BI 144807 PfoS Treatment C
BI 144807 intermediate doseDRUG

tablet

BI 144807 Tab Treatment F

Eligibility Criteria

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

You may qualify if:

  • \- Healthy male subjects

You may not qualify if:

  • \- Any relevant deviation from healthy condition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1313.9.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 12, 2013

Study Start

July 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 6, 2013

Record last verified: 2013-09

Locations

DE(1)