Single Rising Dose Study of BI 135585 XX in Health Asian Male Volunteers.

October 31, 2013 updated by: Boehringer Ingelheim

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Oral Doses (12.5 mg, 50 mg, 200 mg) of BI 135585 XX (Tablet) in Chinese and Japanese Healthy Male Volunteers (Randomised, Double-blind,Placebo-controlled Within Dose Groups)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • 1283.5.82001 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

  1. Healthy male volunteers,
  2. Chinese or Japanese ethnicity

Exclusion criteria:

  1. 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
  2. Any evidence of a clinically relevant concomitant disease
  3. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 135585 XX
single dose of BI 135585
Drug: BI 135585 XX
single dose of low, medium or high dose of BI 135585 XX
Placebo Comparator: matching placebo
single dose of matching placebo
Drug: Matching placebo
single dose of matching placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in Vital signs (blood pressure (BP), pulse rate (PR), respiratory rate(RR))
Time Frame: up to 21 days
up to 21 days
Changes in 12-lead ECG (electrocardiogram)
Time Frame: up to 21 days
up to 21 days
Changes in Clinical laboratory tests (haematology, clinical chemistry and urinalysis)
Time Frame: up to 21 days
up to 21 days
Occurrence of Adverse events
Time Frame: up to 21 days
up to 21 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Cmax (maximum measured concentration of the analyte in plasma)
Time Frame: 10 days
10 days
Tmax (maximum measured concentration of the analyte in plasma)
Time Frame: 10 days
10 days
AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time Frame: 10 days
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

February 7, 2011

First Submitted That Met QC Criteria

February 7, 2011

First Posted (Estimate)

February 8, 2011

Study Record Updates

Last Update Posted (Estimate)

November 1, 2013

Last Update Submitted That Met QC Criteria

October 31, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 1283.5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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