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

Study Overview
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Brief Summary
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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.

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

Conditions
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Human Volunteers

Intervention / Treatment
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* Drug: BMN 673


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment A<br>Period 1: fasted control → Period 2: fed control | Drug: BMN 673<br>* 500mcg dose of BMN 673, 2 discrete single doses separated by 21 days<br>|
| Experimental: Treatment B<br>Period 1: fed control → Period 2: fasted control | Drug: BMN 673<br>* 500mcg dose of BMN 673, 2 discrete single doses separated by 21 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 |