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

Study Overview
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Brief Summary
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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.

Official Title
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A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP ANALGESIC EFFICACY TRIAL OF ORAL ARRY-371797 IN SUBJECTS UNDERGOING THIRD MOLAR EXTRACTION

Conditions
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Dental Pain

Intervention / Treatment
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* Drug: ARRY-371797, p38 inhibitor; oral
* Drug: Placebo; oral
* Drug: Placebo; oral
* Drug: ARRY-371797, p38 inhibitor; oral


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-371797<br> | Drug: ARRY-371797, p38 inhibitor; oral<br>* dose 1, dose 2<br>|
| Experimental: Placebo, ARRY-371797<br> | Drug: Placebo; oral<br>* dose 1<br>Drug: ARRY-371797, p38 inhibitor; oral<br>* dose 2<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo; oral<br>* dose 1, dose 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of the study drug dosed either perioperatively or postoperatively in terms of total pain relief (TOTPAR) and total pain intensity (visual analog scale, VAS). |  | 6 hours post dose 2 | 
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, electrocardiograms and vital signs. |  | Duration of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare the efficacy of the study drug dosed perioperatively versus postoperatively in terms of total pain intensity (VAS). |  | Duration of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Analgesia