Skip to main content
OpenTrials
Completed

NCT Number: NCT01291732

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

20 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1283.5.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy male volunteers,
  • Chinese or Japanese ethnicity

Exclusion criteria

  • 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

Treatment and study plan

Matching Placebo

Drug

single dose of matching placebo

BI 135585 XX

Drug

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

Primary outcomes

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

    Time frame: up to 21 days

  2. Changes in 12-lead ECG (electrocardiogram)

    Time frame: up to 21 days

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

    Time frame: up to 21 days

  4. Occurrence of Adverse events

    Time frame: up to 21 days

Secondary outcomes

  1. Cmax (maximum measured concentration of the analyte in plasma)

    Time frame: 10 days

  2. Tmax (maximum measured concentration of the analyte in plasma)

    Time frame: 10 days

  3. 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

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

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)

Important dates

Study start
2011
Primary completion
2011
First posted
Feb 8, 2011
Registry last updated
Nov 1, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.