Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction

Single-Center, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Proof-of-Concept Study to Evaluate the Safety, PK, & Efficacy of a Single Oral Dose of XPF-001 in the Treatment of Pain Related to Third Molar/Wisdom Tooth Extraction.

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

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.