Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
Condition: Neurocysticercosis
MeSH terms: Neurocysticercosis; Cysticercosis; Taeniasis
Intervention: Oxfendazole; Placebo
Intervention description: A benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7.; Normal Saline administered with an oral dosing syringe. Group 1- Group 6
Intervention MeSH terms: Oxfendazole
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 70.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: neurocysticercosis; pork tapeworm; Taenia solium

Summary:

      The objectives of the Phase I study are to evaluate the safety and tolerance of increasing
      single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the
      pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The
      description of agent used is single oral dose of an aqueous suspension of oxfendazole, a
      benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two
      week safety data for the preceding group have been reviewed. If a clinically significant AE
      is observed, and if this event is drug-related the safety monitoring committee will be
      convened to determine whether the study should continue.
    

Eligibility criteria:

        Inclusion Criteria:

        1. Males and females of non-childbearing potential between the ages of 18 and 45 years,
        inclusive.* *Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy
        or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels. 2. In good
        health, as judged by the investigator and determined by vital signs* Temperature < 38
        degrees Celsius, heart rate </=100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg
        and > 89 mmHg, diastolic blood pressure </=90 mmHg and >/= 60 mm Hg, medical history and a
        targeted physical examination. BMI >/=18 and </= 35. Athletically trained subjects with a
        pulse >/= 45 may be enrolled at the discretion of the principal investigator or designated
        licensed clinical investigator. 3. Acceptable screening laboratories* *Hemoglobin, white
        blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges.
        AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper
        limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values
        below the normal range are acceptable). Random blood glucose must be <140. Urine dipstick
        testing must be negative for glucose and negative or trace for protein. The following
        serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and
        hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be
        performed for individuals suspected of having indeterminate antibody testing. 4. Male
        participants must be willing to ensure use of condoms and spermicides for 4 months after
        study drug administration. 5. Provide written informed consent before initiation of any
        study procedures. 6. Willing to be available for all study-required procedures, and visits
        for the duration of the study. 7. Able to provide a home phone number, and the name,
        address, and/or email of a person willing to assist with making contact during the
        follow-up phase of the study.

        Exclusion Criteria:

        1. History of residing for 6 or more months in regions with endemic cysticercosis as
        determined by the principal investigator or a designated study physician. 2. Breastfeeding
        females. 3. Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute
        illness within 3 days before administration of study drug (subject may be rescheduled). 4.
        Chronic or acute medical disorder* *Disorders of the cardiac, pulmonary, liver, kidney,
        neurologic, gastrointestinal or other system, such that in the opinion of the investigator
        participation in the study creates additional risk to the subject, or to the validity of
        the study. 5. Use of chronic systemic medications* *Intermittent use of over the counter
        medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for
        enrollment (please see section 5.6 for instructions on medication use during the
        study).Topical medications, nasal steroids are permitted throughout the study. Use of the
        prescription medications used less than once per week on average are permitted for
        enrollment (see section 5.6 for instructions on medication use during the study). If the
        subject has taken a short term prescription medication within the past 30 days (e.g. an
        antibiotic), they should be postponed from enrollment until 30 days have elapsed since the
        last dose 6. Has history of sensitivity to related benzimidazole compounds (e.g.,
        albendazole, mebendazole). 7. A diagnosis of schizophrenia, bipolar disease, or history of
        hospitalization for a psychiatric condition or previous suicide attempt. 8. A history of
        treatment for any other psychiatric disorder in the past 3 years.* *Past treatment for ADHD
        does not exclude participants from enrollment as long as the medications have been
        discontinued for a minimum of 3 months and symptoms are well controlled. 9. Received an
        experimental agent* within 1 month before administration of study drug or expect to receive
        an experimental agent during the 15-day study period. *Vaccine, drug, biologic, device,
        blood product, or medication. 10. Any condition that would, in the opinion of the
        investigator, place them at an unacceptable risk of injury, render them unable to meet the
        requirements of the protocol, or that may interfere with successful completion of the
        study. 11. A history of alcohol consumption* or any illicit drug use†, or history of
        substance abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours
        prior to enrollment through day 15. *Greater than 7 alcoholic drinks per week. †Other than
        occasional marijuana use (less than once per week for the past 60 days is acceptable).
        #Alcohol or illicit drugs within the past 3 years. 12. History of chronic tobacco use in
        the past 60 days.* *A history of occasional tobacco use (less than 1 pack per week on
        average) is acceptable. Individuals will be counseled to abstain from use of tobacco and
        marijuana from screening through day 15.