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

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ClinicalTrials.gov Identifier: NCT01510782
Recruitment Status : Completed
First Posted : January 16, 2012
Last Update Posted : November 1, 2013
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
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 or disease Intervention/treatment Phase
Healthy Drug: Placebo to BI 655064 Drug: BI 655064 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
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)
Study Start Date : January 2012
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Arm Intervention/treatment
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



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any relevant deviation from healthy conditions


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01510782


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01510782     History of Changes
Other Study ID Numbers: 1293.1
2011-002251-34 ( EudraCT Number: EudraCT )
First Posted: January 16, 2012    Key Record Dates
Last Update Posted: November 1, 2013
Last Verified: October 2013