Clincosm LogoSign in Get a demo

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

Sponsor
Pfizer (Industry)
Overall Status
Completed
CT.gov ID
NCT01776437
Collaborator
(none)
18
Enrollment
1
Location
2
Arms
4.9
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Drug: BMN 673
 Phase 1

Study Design

Study Type:
Interventional
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 :
Feb 1, 2013
Actual Primary Completion Date :
May 1, 2013
Actual Study Completion Date :
Jul 1, 2013

Arms and Interventions

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

Outcome Measures

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. [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. [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Covance Clinical Research Unit Inc. Evansville Indiana United States 47710

Sponsors and Collaborators

  • Pfizer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pfizer
ClinicalTrials.gov Identifier:
NCT01776437
Other Study ID Numbers:
  • 673-103
First Posted:
Jan 28, 2013
Last Update Posted:
Jul 28, 2017
Last Verified:
Jul 1, 2017
Additional relevant MeSH terms:
Talazoparib

Study Results

No Results Posted as of Jul 28, 2017