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

NCT ID: NCT01776437

Last Updated: 2017-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2013-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Treatment A

Period 1: fasted control → Period 2: fed control

Group Type: EXPERIMENTAL

BMN 673

Intervention Type: DRUG

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

Treatment B

Period 1: fed control → Period 2: fasted control

Group Type: EXPERIMENTAL

BMN 673

Intervention Type: DRUG

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

Interventions

BMN 673

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

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Covance Clinical Research Unit Inc.

Evansville, Indiana, United States

Countries

United States

Other Identifiers

673-103

Identifier Type: -

Identifier Source: org_study_id