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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01510782
First received: January 12, 2012
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: Placebo to BI 655064
Drug: BI 655064
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Changes in vital signs (blood pressure [BP], pulse rate [PR]) [ Time Frame: up to 70 days post treatment ] [ Designated as safety issue: No ]
  • Changes in 12-lead ECG (electrocardiogram) [ Time Frame: up to 70 days post treatment ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: up to 70 days post treatment ] [ Designated as safety issue: No ]
  • Assessment of global tolerability by investigator [ Time Frame: up to 70 days post treatment ] [ Designated as safety issue: No ]
  • Assessment of local tolerability by investigator [ Time Frame: up to 70 days post treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum measured concentration of the analyte in plasma [ Time Frame: up to 1656 hours post treatment ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: January 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 655064 subcutaneous
Escalating single dose as solution for subcutaneous injection
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
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
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01510782

Locations
Germany
1293.1.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

No publications provided

Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01510782     History of Changes
Other Study ID Numbers: 1293.1, 2011-002251-34
Study First Received: January 12, 2012
Last Updated: October 31, 2013
Health Authority: Germany: Paul-Ehrlich-Institute

ClinicalTrials.gov processed this record on July 29, 2014