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

A Phase 1 Food Effect Study of BMN 673 Administered to Healthy Adult Male Volunteers

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.

Study Overview

• Status: Completed
• Conditions: Human Volunteers
• Intervention / Treatment: Drug: BMN 673

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Evansville, Indiana, United States, 47710
      • Covance Clinical Research Unit Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pfizer

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): May 1, 2013
• Study Completion (Actual): July 1, 2013

Study Registration Dates

• First Submitted: January 24, 2013
• First Submitted That Met QC Criteria: January 24, 2013
• First Posted (Estimate): January 28, 2013

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 26, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antineoplastic Agents; Poly(ADP-ribose) Polymerase Inhibitors; Talazoparib
• Other Study ID Numbers: 673-103