Safety and Efficacy Study of XPF-001 to Treat Pain Following Wisdom Tooth Extraction
Condition: Dental Pain
MeSH terms: Toothache
Intervention: XPF-001; placebo
Intervention description: Single oral administration of 500 mg XPF-001 capsules (5 x 100 mg capsules); Single oral administration of 5 x 100 mg Placebo capsules.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 61.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pain following 3rd molar/wisdom tooth extraction

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.