COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
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
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
Germany
1294.1.1 Boehringer Ingelheim Investigational Site
Berlin, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Layout table for investigator information
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
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