Clinical trial: Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers (NCT03035760)

Eligibility criteria:
Inclusion Criteria:

          1. Males and nonpregnant females between the ages of 18 and 45 years, inclusive.

          2. Women of childbearing potential* must agree to practice adequate contraception** for
             the 28-day period before Day 0 through 4 months after the last dose of study
             medication.

             * A woman is considered of childbearing potential unless surgically sterile (tubal
             ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal (=1 year).

             **Acceptable birth control methods include but are not limited to: abstinence from
             sexual intercourse with men; monogamous relationship with a vasectomized partner;
             double-barrier methods (condoms, diaphragms, spermicides); intrauterine devices; and
             licensed hormonal methods.

          3. In good health, as judged by the investigator and determined by vital signs*

             *Temperature < 38°C, 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. Acceptable screening
             laboratories: Hemoglobin, white blood cell (WBC) count, neutrophil, and platelet
             counts, INR and PTT within normal ranges. AST < 44 and ALT < 44 and total bilirubin,
             creatinine must be equal to or below the upper limit of normal (creatinine 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 the last dose study medication.

          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. Individuals must agree to abstain from drug or alcohol use for 48 hours prior to
             enrollment through day 10 or 14.

          8. 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. Pregnant women, women who are planning to become pregnant in the next 4 months, or
             women who are breastfeeding.

          2. Body temperature >=100.4°F (>=38.0°C) or acute illness within 3 days before
             administration of study drug (subject may be rescheduled).

          3. 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.

          4. Use of chronic systemic medications* *Intermittent use of over the counter medications
             such as acetaminophen, ibuprofen, cold and sinus medications are permitted for
             enrollment Topical medications, nasal steroids are permitted throughout the study. Use
             of prescription medications used less than once per week on average are permitted for
             enrollment. 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.

          5. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole,
             mebendazole).

          6. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a
             psychiatric condition or previous suicide attempt.

          7. 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.

          8. Received an experimental agent* within 1 month before administration of study drug or
             expect to receive an experimental agent during the 10 or 14-day study period.

             *Vaccine, drug, biologic, device, blood product, or medication.

          9. Any condition that would, in the opinion of the investigator, interfere with the
             study.*

             *This includes any condition that would 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.

         10. A history of heavy alcohol* or illicit drug use**, or history of substance abuse#.

             *On average, 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.

         11. 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 10
             or 14.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.
Subject must be at most 45 Years

Patient description (medical language): A 19-year-old girl comes to the clinic due to a left wrist mass.  She noticed swelling on the top of her wrist about 4 months ago and came to the clinic due to cosmetic concerns.  Examination shows a nontender, rounded mass on the dorsal wrist that transilluminates with a penlight. Vital signs are normal. The patient needs to type on her computer almost all day. She is left-handed. She does not smoke or use illicit drugs. She is in sexual relationship with two male partners and uses condoms.

Patient description (patient's own words): I'm a 19-year-old girl and I went to see my doctor because of a mass on my left wrist. I noticed a swelling on top of my wrist, like 4 months ago, and I went the first time to the doctor because it was pretty ugly! My wrist was not tender, and the mass was round and let the light go through when the doctor used a penlight. My blood pressure, breathing and temperature were normal. I'm left-handed and I need to be on my PC all day. I don't smoke or do drugs. I'm sexually active and I have 2 male partners but they all use condoms.

Does the patient match the trial criteria? 1