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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01650155
First received: July 18, 2012
Last updated: July 10, 2013
Last verified: July 2013
  Purpose

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 Intervention 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 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 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)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • number (% subjects) with drug-related AEs. [ Time Frame: day -21 to day 95 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of the analyte in plasma) [ Time Frame: day 1 to day 90 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 88
Study Start Date: July 2012
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01650155

Locations
Germany
1294.1.1 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: NCT01650155     History of Changes
Other Study ID Numbers: 1294.1, 2011-004987-30
Study First Received: July 18, 2012
Last Updated: July 10, 2013
Health Authority: Germany: Paul-Ehrlich-Institut

ClinicalTrials.gov processed this record on April 17, 2014