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Single Rising Dose Study With Intravenous Infusion and Subcutaneous Injection of BI 1005273 in Healthy Male Volunteers.

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ClinicalTrials.gov Identifier: NCT01650155
Recruitment Status : Completed
First Posted : July 26, 2012
Last Update Posted : October 16, 2014
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Brief Summary:
To investigate the safety and tolerability of BI 1005273 in healthy male volunteers following intravenous (i.v.) infusion of single rising doses and subcutaneous (s.c.) injection. Secondary objectives are the exploration of the pharmacokinetics and early pharmacodynamics of BI 1005273.

Condition or disease Intervention/treatment Phase
Healthy Drug: BI 1005273 s.c. Drug: BI 105273 i.v. Placebo Drug: BI 1005273 s.c. Placebo Drug: BI 1005273 i.v. Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Safety, Tolerability, Pharmacokinetics and Early Pharmacodynamics of Single Rising Intravenous and Subcutaneous Doses of BI 1005273 in Healthy Male Volunteers (Randomised, Single-blind, Placebo-controlled Within Dose Groups, Clinical Phase I Study)
Study Start Date : July 2012
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Experimental: BI 1005273 i.v.
single dose i.v. infusion
Drug: BI 1005273 i.v.
infusion

Placebo Comparator: BI 1005273 i.v. Placebo
single dose i.v. infusion (Placebo)
Drug: BI 105273 i.v. Placebo
infusion

Experimental: BI 1005273 s.c.
single dose s.c. injection
Drug: BI 1005273 s.c.
injection

Placebo Comparator: BI 1005273 s.c. Placebo
single dose s.c. injection (Placebo)
Drug: BI 1005273 s.c. Placebo
injection




Primary Outcome Measures :
  1. number (% subjects) with drug-related AEs. [ Time Frame: day -21 to day 95 ]

Secondary Outcome Measures :
  1. Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: day 1 to day 90 ]
  2. AUC0-8 (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: day 1 to day 90 ]
  3. AUC0-tz (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: day 1 to day 90 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

1. Healthy male subjects

Exclusion criteria:

1. Any 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): NCT01650155


Locations
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Germany
1294.1.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01650155    
Other Study ID Numbers: 1294.1
2011-004987-30 ( EudraCT Number: EudraCT )
First Posted: July 26, 2012    Key Record Dates
Last Update Posted: October 16, 2014
Last Verified: October 2014