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Trial record 1 of 1 for:    NCT01776437
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Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers

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ClinicalTrials.gov Identifier: NCT01776437
Recruitment Status : Completed
First Posted : January 28, 2013
Last Update Posted : July 28, 2017
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE January 24, 2013
First Posted Date  ICMJE January 28, 2013
Last Update Posted Date July 28, 2017
Study Start Date  ICMJE February 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
The primary outcome of this study is to evaluate the effect of food on the relative bioavailability of BMN 673. The Pharmacokinetic analyses of plasma BMN 673 concentration-time will be measured using non-compartmental methods. [ Time Frame: 4 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01776437 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2013)
Assess the safety and tolerability of BMN 673 during fasting and fed conditions with the following safety assessments: adverse events, physical examination, vital signs, concomitant medications, clinical laboratory tests and ECG. [ Time Frame: 4 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
Official Title  ICMJE A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers
Brief Summary This is a randomized, 2-period, 2-sequence crossover study to evaluate the effect of food on the relative bioavailability of BMN 673 during fasting and fed conditions in healthy male subjects.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Human Volunteers
Intervention  ICMJE Drug: BMN 673
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
Study Arms  ICMJE
  • Experimental: Treatment A
    Period 1: fasted control → Period 2: fed control
    Intervention: Drug: BMN 673
  • Experimental: Treatment B
    Period 1: fed control → Period 2: fasted control
    Intervention: Drug: BMN 673
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 24, 2013)
18
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date May 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male, between the ages of 18 and 55.
  • Non-smoking for at least 1 year before Screening.
  • Willing and able to provide informed consent.
  • Have a BMI between 18 to 30kg/m2.
  • Willing and able to comply all study procedures.
  • Have adequate organ function
  • Sexually active patients must be willing to use an acceptable method of contraception.

Exclusion Criteria:

  • History of any illness that might confound the results of the study or pose an additional risk in administering study medication to the subject.
  • Current use of prescription medication or regular treatment with over-the-counter medications.
  • Consumption of herbal medications or dietary supplements.
  • Consumption of more that than 3 units of alcoholic beverages per day.
  • Consumption of more than five 240-mL servings of coffee or other caffeinated beverage.
  • History of alcohol or drug abuse or addiction within 6 months of study entry.
  • Participation in a clinical Study involving administration of an investigational drug within 1 month or 5 half lives (whichever is longer).
  • Donation of any blood or having had a significant loss of blood with 56 days.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01776437
Other Study ID Numbers  ICMJE 673-103
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pfizer
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP