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

Pfizer

Status and phase

Completed

Phase 1

Conditions

Human Volunteers

Treatments

Drug: BMN 673

Study type

Interventional

Funder types

Industry

Identifiers

NCT01776437

673-103

Details and patient eligibility

About

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.

Enrollment

18 patients

Sex

Male

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.