We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01594515
First Posted: May 9, 2012
Last Update Posted: December 15, 2015
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.
Information provided by (Responsible Party):
Boehringer Ingelheim
  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
Intervention Model: Parallel Assignment
Masking: Single
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. ]
    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). ]
    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). ]
    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). ]
    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. ]
    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. ]
    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 ]
    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 ]
    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

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.


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 relevant deviation from healthy conditions

  Contacts and Locations
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): 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 ( EudraCT Number: EudraCT )
First Submitted: May 7, 2012
First Posted: May 9, 2012
Results First Submitted: November 11, 2015
Results First Posted: December 15, 2015
Last Update Posted: December 15, 2015
Last Verified: November 2015

Additional relevant MeSH terms:
Pharmaceutical Solutions