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

October 31, 2013 updated by: Boehringer Ingelheim

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

72

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

  • Germany
      • Berlin, Germany
        • 1293.1.1 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

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

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: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BI 655064 subcutaneous
Escalating single dose as solution for subcutaneous injection
Drug: BI 655064
intravenous infusion of escalating doses
Drug: BI 655064
subcutaneous injection of escalating doses
Placebo Comparator: Placebo to BI 655064 subcutaneous
Escalation single dose as solution for subcutaneous injection (Placebo)
Drug: Placebo to BI 655064
intravenous infusion of escalating doses
Drug: Placebo to BI 655064
subcutaneous injection of escalating doses
Experimental: BI 655064 intravenous
Escalating single dose as solution for intravenous infusion
Drug: BI 655064
intravenous infusion of escalating doses
Drug: BI 655064
subcutaneous injection of escalating doses
Placebo Comparator: Placebo to BI 655064 intravenous
Escalating single dose as solution for intravenous infusion (Placebo)
Drug: Placebo to BI 655064
intravenous infusion of escalating doses
Drug: Placebo to BI 655064
subcutaneous injection of escalating doses

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in vital signs (blood pressure [BP], pulse rate [PR])
Time Frame: up to 70 days post treatment
up to 70 days post treatment
Changes in 12-lead ECG (electrocardiogram)
Time Frame: up to 70 days post treatment
up to 70 days post treatment
Incidence of adverse events
Time Frame: up to 70 days post treatment
up to 70 days post treatment
Assessment of global tolerability by investigator
Time Frame: up to 70 days post treatment
up to 70 days post treatment
Assessment of local tolerability by investigator
Time Frame: up to 70 days post treatment
up to 70 days post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum measured concentration of the analyte in plasma
Time Frame: up to 1656 hours post treatment
up to 1656 hours post treatment
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
up to 1656 hours post treatment
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
up to 1656 hours post treatment

Collaborators and Investigators

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

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

September 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 12, 2012

First Submitted That Met QC Criteria

January 12, 2012

First Posted (Estimate)

January 16, 2012

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

  • 1293.1
  • 2011-002251-34 (EudraCT Number: EudraCT)

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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