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
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, see Learn About Clinical Studies.

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 October 16, 2014