safety and efficacy study of xpf-001 to treat pain following wisdom tooth extraction

Conditions: Dental Pain

Summary: the purpose of this trial is to determine if xpf-001 is effective for the treatment of pain following third-molar/wisdom tooth extraction.


Eligibility criteria:
inclusion criteria: * males (aged 18-60) and females of non-childbearing potential (aged 18-60; * bmi between 19.5 to 32.0 kg/m2; * outpatient, scheduled to undergo surgical extraction of 2 or more impacted 3rd molars (with at least 1 partial bony mandibular extraction); * use of only the following preoperative medications 2% lidocaine with epinephrine and nitrous oxide; * able to complete the requested information on analgesic questionnaires and able to comply with study procedures and restrictions; * able to read, comprehend and sign the consent form; * deemed medically healthy to participate in the study, with normal or clinically insignificant medical history, physical examination, lab tests and ecg results; * no contraindications to the study drug, it excipients or any of the study medications including rescue medications. exclusion criteria: * presence of a clinically significant medical condition; * positive test for hiv, hepatitis b or hepatitis c; * use of any prescription or over the counter medication or supplement in the 48 hours before dose of study drug until discharge; * acute local infection at the time of dental surgery; * females who are pregnant, lactating or of child-bearing potential, or who provide a positive pregnancy test result at screening or check-in; * males not undertaking adequate measures to prevent their partner becoming pregnant throughout the study; * clinically significant laboratory values; * clinically significant abnormal ecg; * history or presence of alcoholism, or alcohol or substance abuse (within previous 2 years), or routine consumption of 3 or more alcoholic drinks per day; * a positive urine drug test; * routine use of analgesics 5 or more times per week; * presence or history (within 2 years of enrolment) of bleeding disorder(s) or peptic ulcer disease; * history of allergic reaction to any drug, including penicillin; * ingestion of caffeine containing foods or drinks in the 24 hours before dose of study drug; * consumption of alcohol in the 48 hours before dose of study drug, or a positive alcohol breath test at check-in; * consumption of grapefruit or grapefruit containing products in the 7 days before dose of study drug; * use of tobacco or nicotine substitutes within 1 month of dose of study drug, or inability to refrain from use of nicotine between check-in and follow up; * treatment for depression in the 6 months prior to enrolment; * use of another investigational drug in the 60 days before enrolment; * donation or loss of 50-500 ml of blood in the 30 days prior to enrolment, or more than 500 ml of blood in the 56 days before enrolment; * previously entered into this study; * study site or sponsor employees or relatives of employees directly involved in the study; * any other condition that (in the opinion of the investigator or sponsor) makes the subject unsuitable for the study.

Keywords: pain following 3rd molar/wisdom tooth extraction