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: November 11, 2015
Last verified: November 2015
  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 Subjects With Drug Related Adverse Events [ Time Frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. ] [ Designated as safety issue: No ]
    Percentage of subjects with drug related adverse events.

  • Number (%) of Subjects With Clinically Relevant Abnormalities in Clinical Laboratory Tests [ Time Frame: Day -21 to -2, upto -72 hours, 4h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). ] [ Designated as safety issue: No ]
    Percentage of subjects with clinically relevant abnormalities in clinical laboratory tests (haematology, clinical chemistry, haemoccult® test, and urinalysis).

  • Number (%) of Subjects With Clinically Relevant Abnormalities in Vital Signs [ Time Frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). ] [ Designated as safety issue: No ]
    Percentage of subjects with clinically relevant abnormalities in vital signs (blood pressure, pulse rate, respiratory rate, oral body temperature, orthostasis test).

  • Number (%) of Subjects With Clinically Relevant Abnormalities in 12-lead ECGs [ Time Frame: Day -21 to -2, -1 hour, 0.5h, 1h, 2h, 4h, 8h, 10h, 24h, 48h, 72h and study examination(within 5 to 7 days after last PK sampling). ] [ Designated as safety issue: No ]
    Percentage of subjects with clinically relevant abnormalities in 12-lead ECGs.

  • Number (%) of Subjects With Clinically Relevant Abnormalities in Tolerability [ Time Frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. ] [ Designated as safety issue: No ]
    Percentage of subjects with clinically relevant abnormalities in tolerability assessed by the investigator.

  • Number (%) of Subjects With Clinically Relevant Abnormalities in Physical Examinations [ Time Frame: From the day of informed consent(-21 days) until the end-of-study examination(within 5 to 7 days after last PK sampling), upto 10 days. ] [ Designated as safety issue: No ]
    Percentage of subjects with clinically relevant abnormalities in physical examinations.


Secondary Outcome Measures:
  • Cmax of BI 1015550 [ Time Frame: −0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing ] [ Designated as safety issue: No ]
    Maximum measured concentration of the analyte in plasma.

  • AUC0-infinity of BI 1015550 [ Time Frame: −0.5hour before dosing and 0.5h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 5h, 6h, 8h, 10h, 12h, 24h, 34h, 48h and 72h after dosing ] [ Designated as safety issue: No ]
    Area under the concentration-time curve in plasma over the time interval from 0 extrapolated to infinity


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 A
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 low dose B
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 low dose C
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 low dose D
Powder for oral solution
Drug: BI 1015550
Low dose powder for oral solution
Experimental: BI 1015550 medium dose A
Powder for oral solution
Drug: BI 1015550
Medium dose powder for oral solution
Experimental: BI 1015550 medium dose B
Powder for oral solution
Drug: BI 1015550
Medium dose powder for oral solution
Experimental: BI 1015550 medium dose C
Powder for oral solution
Drug: BI 1015550
Medium dose powder for oral solution
Experimental: BI 1015550 high dose A
Powder for oral solution
Drug: BI 1015550
High dose powder for oral solution
Experimental: BI 1015550 high dose B
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   (Adult)
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

Additional Information:
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
Results First Received: November 11, 2015
Last Updated: November 11, 2015
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

ClinicalTrials.gov processed this record on July 21, 2016