A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction
This is a Phase 2 study designed to test the ability of investigational study drug
 ARRY-371797 to reduce pain either perioperatively or postoperatively in a third molar
 extraction pain model, and to further evaluate the drug's safety. Approximately 150 subjects
 from the US will be enrolled in this study.
Key Inclusion Criteria:

 -  Scheduled for outpatient oral surgical procedure to remove 2 ipsilateral third molars,
 at least 1 of which is mandibular and fully or partially impacted by bone.

 -  Females of childbearing potential must be willing to use an acceptable method of
 contraception within 14 days prior to first dose of study drug until the completion of
 the follow-up procedures.

 -  Body weight >50 kg (110 lbs).

 -  Good health determined by medical history, physical examination, vital signs and
 clinical laboratory results of non-clinical significance.

 -  Additional criteria exist.

 Key Exclusion Criteria:

 -  Positive urine drug screen.

 -  Use of prescription or nonprescription drugs, herbal or dietary supplements, vitamins,
 or grapefruit juice within 14 days prior to first dose of study drug.

 -  Additional criteria exist.