Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01594515
First received: May 7, 2012
Last updated: March 6, 2013
Last verified: March 2013
  Purpose

In this first-in-man trial, safety, tolerability, pharmacokinetics, and selected pharmacodynamics parameters of BI 1015550 will be assessed in healthy male volunteers.


Condition Intervention Phase
Healthy
Drug: BI 1015550
Drug: Placebo
Drug: BI 101550
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Single Rising Oral Doses of BI 1015550 in Healthy Male Volunteers (a Partially Randomised, Partially Single-blind, Placebo-controlled Phase I Study)

Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Number of participants with clinically relevant findings in physical examination [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]
  • Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]
  • Number of participants with significant changes from baseline laboratory measurements [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]
  • Number of participants with adverse events [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cmax (maximum measured concentration of BI 1015550 in plasma) [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]
  • AUC0-infinity (area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity) [ Time Frame: Up to 22 weeks ] [ Designated as safety issue: No ]

Enrollment: 70
Study Start Date: May 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: BI 1015550 low dose
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 low dose
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 low dose
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 low dose
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 medium dose
Powder for oral solution
Drug: BI 1015550
Medium dose powder for oral solution
Experimental: BI 1015550 medium dose
Powder for oral solution
Drug: BI 1015550
Medium dose powder for oral solution
Experimental: BI 1015550 medium dose
Powder for oral solution
Drug: BI 1015550
Medium dose powder for oral solution
Experimental: BI 1015550 high dose
Powder for oral solution
Drug: BI 1015550
High dose powder for oral solution
Experimental: BI 1015550 high dose
Powder for oral solution
Drug: BI 101550
High dose powder for oral solution
Placebo Comparator: Placebo
Solution for oral administration
Drug: Placebo
Solution for oral administration

  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 relevant deviation from healthy conditions

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594515

Locations
Germany
1305.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, 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: NCT01594515     History of Changes
Other Study ID Numbers: 1305.1, 2012-000405-68
Study First Received: May 7, 2012
Last Updated: March 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on April 15, 2014