Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers

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

Tracking Information

• First Submitted Date: January 24, 2013
• First Posted Date: January 28, 2013
• Last Update Posted Date: July 28, 2017
• Study Start Date: February 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT01776437 on ClinicalTrials.gov Archive Site
• Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Study of BMN 673, a PARP Inhibitor, in Healthy Adult Male Volunteers
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Human Volunteers

Intervention

Drug: BMN 673

500mcg dose of BMN 673, 2 discrete single doses separated by 21 days

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: January 24, 2013): 18
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 2013
• Actual Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 55 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01776437
• Other Study ID Numbers: 673-103
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Pfizer
• Verification Date: July 2017