NCT01291732

Brief Summary

The Aim of the study is to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in Asian healthy males administered a single dose of BI 135585.

Trial Health

80
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

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

February 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 7, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Last Updated

November 1, 2013

Status Verified

October 1, 2013

Enrollment Period

2 months

First QC Date

February 7, 2011

Last Update Submit

October 31, 2013

Conditions

Healthy

Outcome Measures

Primary Outcomes (4)

  • Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))

    up to 21 days

  • Changes in 12-lead ECG (electrocardiogram)

    up to 21 days

  • Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)

    up to 21 days

  • Occurrence of Adverse events

    up to 21 days

Secondary Outcomes (3)

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

    10 days

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

    10 days

  • AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)

    10 days

Study Arms (2)

BI 135585 XX

EXPERIMENTAL

single dose of BI 135585

Drug: BI 135585 XX

matching placebo

PLACEBO COMPARATOR

single dose of matching placebo

Drug: Matching placebo

Interventions

Matching placeboDRUG

single dose of matching placebo

matching placebo
BI 135585 XXDRUG

single dose of low, medium or high dose of BI 135585 XX

BI 135585 XX

Eligibility Criteria

Age20 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers,
  • Chinese or Japanese ethnicity

You may not qualify if:

  • Any finding of the medical examination (including blood pressure (BP), pulse rate (PR) and electrocardiogram (ECG)) deviating from normal and of clinical relevance according to the investigators medical judgement
  • Any evidence of a clinically relevant concomitant disease
  • Intake of drugs with long half life (\>24 hour) within at least one month or less than 10 half-lives of the respective drug prior to administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

1283.5.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

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

Study Record Dates

First Submitted

February 7, 2011

First Posted

February 8, 2011

Study Start

February 1, 2011

Primary Completion

April 1, 2011

Last Updated

November 1, 2013

Record last verified: 2013-10

Locations

KR(1)