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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | Period 1: fasted control → Period 2: fed control |
|
| Treatment B | Experimental | Period 1: fed control → Period 2: fasted control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BMN 673 | Drug | 500mcg dose of BMN 673, 2 discrete single doses separated by 21 days |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit Inc. | Evansville | Indiana | 47710 | United States |
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| ID | Term |
|---|---|
| C586365 | talazoparib |
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