Skip to main content
OpenTrials
Completed

NCT Number: NCT01510782

Single Rising Dose Study (Intravenous Infusion and Subcutaneous Injection) of BI 655064 in Healthy Male Volunteers

To investigate safety and tolerability of BI 655064 in healthy male volunteers following intravenous infusion of escalating single doses and following subcutaneous injection. Exploration of the pharmacokinetics and pharmacodynamics of BI 655064 after single dosing and determination of the bioavailability of subcutaneous injections of BI 655064.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

1293.1.1 Boehringer Ingelheim Investigational Site

Berlin, Germany

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male subjects

Exclusion criteria

  • Any relevant deviation from healthy conditions

Treatment and study plan

Placebo to BI 655064

Drug

intravenous infusion of escalating doses

BI 655064

Drug

intravenous infusion of escalating doses

Primary outcomes

  1. Changes in vital signs (blood pressure [BP], pulse rate [PR])

    Time frame: up to 70 days post treatment

  2. Changes in 12-lead ECG (electrocardiogram)

    Time frame: up to 70 days post treatment

  3. Incidence of adverse events

    Time frame: up to 70 days post treatment

  4. Assessment of global tolerability by investigator

    Time frame: up to 70 days post treatment

  5. Assessment of local tolerability by investigator

    Time frame: up to 70 days post treatment

Secondary outcomes

  1. Maximum measured concentration of the analyte in plasma

    Time frame: up to 1656 hours post treatment

  2. Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity

    Time frame: up to 1656 hours post treatment

  3. Area under the concentration-time curve of the analyte in the plasma over the time interval from 0 to the last measurable time point of the dose

    Time frame: up to 1656 hours post treatment

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Rising Doses (0.2 mg to 120 mg Administered by Intravenous Infusion and 40 mg to 120 mg Administered by Subcutaneous Injection) of BI 655064 (Buffer Solution for Injection) in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jan 16, 2012
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.