A Study of ARRY-371797 in Subjects Undergoing Third Molar Extraction

• Status: Completed
• Trial end date: 2008-02-11
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Array BioPharma; Pfizer

Criteria

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.