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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

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.

Condition or disease Intervention/treatment Phase
Human Volunteers Drug: BMN 673 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
Experimental: Treatment A
Period 1: fasted control → Period 2: fed control
Drug: BMN 673
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
Experimental: Treatment B
Period 1: fed control → Period 2: fasted control
Drug: BMN 673
500mcg dose of BMN 673, 2 discrete single doses separated by 21 days



Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT01776437


Locations
United States, Indiana
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
Pfizer

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01776437     History of Changes
Other Study ID Numbers: 673-103
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: July 28, 2017
Last Verified: July 2017

Additional relevant MeSH terms:
Talazoparib
Poly(ADP-ribose) Polymerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents