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

NCT01776437 | Completed Phase 1

• 1 other identifier: 673-103
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Volunteers

Outcome Measures

Primary Outcomes (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 Outcomes (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

Study Arms (2)

Treatment A

EXPERIMENTAL

Period 1: fasted control → Period 2: fed control

Drug: BMN 673

Treatment B

EXPERIMENTAL

Period 1: fed control → Period 2: fasted control

Drug: BMN 673

Interventions

BMN 673 DRUG

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

Treatment A; Treatment B

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

Evansville, Indiana, 47710, United States

Location

MeSH Terms

Interventions

talazoparib

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2013
• First Posted: January 28, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

US (1)