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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BioMarin Pharmaceutical
ClinicalTrials.gov Identifier:
NCT01776437
First received: January 24, 2013
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Human Volunteers
Drug: BMN 673
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers

Further study details as provided by BioMarin Pharmaceutical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: February 2013
Study Completion Date: July 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders 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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01776437

Locations
United States, Indiana
Covance Clinical Research Unit Inc.
Evansville, Indiana, United States, 47710
Sponsors and Collaborators
BioMarin Pharmaceutical
Investigators
Study Director: Andrew Dorr, MD BioMarin Pharmaceutical
  More Information

No publications provided

Responsible Party: BioMarin Pharmaceutical
ClinicalTrials.gov Identifier: NCT01776437     History of Changes
Other Study ID Numbers: 673-103
Study First Received: January 24, 2013
Last Updated: May 21, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 16, 2014