NCT01286571

Brief Summary

The objective of this study is to investigate the effect of food on the relative bioavailability of a 50 mg BI 135585 XX tablet.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

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

January 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

January 28, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 31, 2011

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

January 28, 2011

Last Update Submit

October 31, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

  • Area under the concentration-time curve of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity

    up to 144 hours post treatment

  • Maximum measured concentration of the analyte in plasma of BI 135585 in plasma over the time interval from 0 hours extrapolated to infinity

    up to 144 hours post treatment

Secondary Outcomes (14)

  • 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 144 hours post treatment

  • Physical examination (occurrence of findings)

    up to 14 days post treatment

  • %AUCtz-∞ (percentage of AUC0-∞ obtained by extrapolation)

    up to 144 hours post treatment

  • tmax (time from dosing to maximum measured concentration)

    up to 144 hours post treatment

  • λz (terminal rate constant in plasma)

    up to 144 hours post treatment

  • +9 more secondary outcomes

Study Arms (2)

BI 135585 (T)

EXPERIMENTAL

single dose per subject as tablet formulation after high fat, high caloric meal

Drug: BI 135585

BI 135585 (R)

EXPERIMENTAL

single dose per subject as tablet formulation after an overnight fast

Drug: BI 135585

Interventions

BI 135585DRUG

one oral single dose per subject

BI 135585 (T)

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 conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1283.3.1 Boehringer Ingelheim Investigational Site

Biberach, Germany

Location

MeSH Terms

Interventions

6-(2-hydroxy-2-methylpropyl)-3-(1-(4-(1-methyl-2-oxo-1,2-dihydropyridin-4-yl)phenyl)ethyl)-6-phenyl-1,3-oxazinan-2-one

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

Study Record Dates

First Submitted

January 28, 2011

First Posted

January 31, 2011

Study Start

January 1, 2011

Primary Completion

March 1, 2011

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

DE(1)