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Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution

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ClinicalTrials.gov Identifier: NCT01835899
Recruitment Status : Completed
First Posted : April 19, 2013
Results First Posted : January 22, 2016
Last Update Posted : January 22, 2016
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
To investigate safety, tolerability, and pharmacokinetics of multiple rising oral doses of BI 1015550 in healthy male volunteers

Condition or disease Intervention/treatment Phase
Healthy Drug: Placebo Drug: BI 1015550 Drug: BI1015550 Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Safety, Tolerability and Pharmacokinetics of Multiple Rising Oral Doses of BI 1015550 Powder for Oral Solution in Healthy Male Volunteers q.d. or b.i.d.for 14 Days (a Randomised, Double-blind, Placebo-controlled Within Dose Groups Phase I Trial)
Study Start Date : April 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo to BI 1015550
placebo
 Drug: Placebo
Placebo to BI 1015550
Experimental: BI 1015550 low dose 1
powder for oral solution
 Drug: BI 1015550
low dose 1 powder for oral solution
Experimental: BI 1015550 low dose 2
powder for oral solution
 Drug: BI1015550
low dose 2 powder for oral solution
Experimental: BI 1015550 medium dose 1
powder for oral solution
 Drug: BI 1015550
medium dose 1 powder for oral solution
Experimental: BI 1015550 medium dose 2
powder for oral solution
 Drug: BI 1015550
medium dose 2 powder for oral solution


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Subjects With Drug-related Adverse Events [ Time Frame: From first drug administration until last drug administration, upto 18 days. ]
    Percentage of subjects with drug related Adverse events, as assessed by the investigator.


Secondary Outcome Measures :
  1. Cmax [ Time Frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. ]
    Maximum measured concentration of BI 1015550 in plasma.

  2. AUCt,1 [ Time Frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h and 12h after first drug administration ]
    Area under the concentration-time curve of BI 1015550 in plasma over a uniform dosing interval t after administration of the first dose

  3. AUC0-infinity [ Time Frame: 0:15h(hours); 0:30h; 0:45h; 1h;1:15h;1:30h; 2h;3h; 4h; 6h; 8h;10h; 12h; 24h; 34h and 47:55h after first drug administration. ]
    Area under the concentration-time curve of BI 1015550 in plasma over the time interval from 0 extrapolated to infinity.

  4. Cmax,ss [ Time Frame: 311:55h (hours); 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h; 324h; 336h; 346h; 360h; 384h & 408h after first drug administration; last drug administration was at 312 h. ]
    Maximum measured concentration of BI 1015550 in plasma at steady state over a uniform dosing interval t.

  5. AUCt,ss [ Time Frame: 311:55h; 312:15h; 312:30h; 312:45; 313h; 313:15h; 313:30h; 314h; 315h; 316h; 318h; 320h; 322h and 324h after first drug administration; last drug administration was at 312 h. ]
    Area under the concentration-time curve of BI 1015550 in plasma at steady state over a uniform dosing interval t.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 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
  2. Subjects unable to understand or to comply with study requirements
Contacts and Locations
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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): NCT01835899


Locations
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Germany
1305.2.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01835899    
Other Study ID Numbers: 1305.2
2012-005614-19 ( EudraCT Number: EudraCT )
First Posted: April 19, 2013    Key Record Dates
Results First Posted: January 22, 2016
Last Update Posted: January 22, 2016
Last Verified: December 2015