A Safety and Efficacy Study of Different Doses of Oxfendazole Compared to a Single Dose of Albendazole to Treat Trichuris Trichiura Infection in Adults

This is an interventional treatment trial for Trichuriasis focused on measuring Adults, Albendazole, Comparative Study, Efficacy, Oxfendazole, Phase 2, Trichuris trichiura Read More

Inclusion Criteria:

1. Male or female aged 18-65 years, inclusive.
2. Are willing to participate in this trial, as evidenced by written or witnessed oral informed consent.

3. T. trichiura* is demonstrated in a stool sample obtained within 14 days before randomization and enrollment.

   *The presence of A. lumbricoides, N. americanus, A. duodenalis, or other helminths will not be a cause for exclusion.

4. Are willing to comply with the requirements of this protocol, particularly to provide four stool samples and two blood samples* over approximately 4- 6 weeks.

   *An extra stool or blood sample might be required if the samples are not collected within the appropriate time frame or to follow up on abnormal laboratory tests.

5. Females of reproductive potential must have a negative serum pregnancy test within 10 days or a negative urine pregnancy test within 72 hours of the first study drug administration.*

   *If a woman of child bearing potential is on an injectable form of contraception, a single serum pregnancy test at screening (Days -10 to -3) is acceptable. If the woman is not using an injectable form of contraception, a pregnancy test must be negative within 72 hours of the first study drug administration.

6. Female subjects of childbearing potential must be using effective contraception.* *Effective methods of contraception include: abstinence from sexual intercourse, monogamous relationship with a vasectomized partner, male condoms with spermicide, surgical sterility, intrauterine contraceptive device, oral or injectable contraceptives, diaphragm in combination with contraceptive cream or foam. Females aged >/=50 years who have had no menstrual periods for 1 year may be enrolled. Females must agree to continue effective contraception for approximately 28 days following the last study drug administration.

Exclusion Criteria:

1. Has demonstrated a previous hypersensitivity reaction to oxfendazole or a related compound (e.g. albendazole, mebendazole).

2. Has a diarrheal disease that would interfere with the evaluation of stool samples*.

   * More than 6 stools per day or stools that are completely liquid.

3. Has received an antihelminthic within 14 days before enrolment.
4. Has received an investigational drug within 30 days before the screening visit or is scheduled to receive such a drug during this trial.
5. Has a concomitant infection or another underlying disease that would compromise the safety, diagnosis, and evaluation of responses to the study drug.
6. Has a known history of renal dysfunction or plasma creatinine >/=1.5 times the upper limit of normal (ULN) for age.
7. Has a known history of hepatic dysfunction or AST, ALT, total bilirubin >/=1.5 times the ULN.
8. Has a hemoglobin that is less than 8 g/dL.
9. Is a female who is pregnant, lactating, or planning a pregnancy during this trial (up to days 28 after the last scheduled dose).
10. Has previously been enrolled in this trial.
11. Has any condition that would, in the investigator's opinion, interfere with this trial.