Single Ascending Dose Safety Study of Oxfendazole (OXFEND-02)

Johns Hopkins Bloomberg School of Public Health

Status and phase: Withdrawn; Phase 1

Conditions: Tenia Solium Infection

Treatments: Drug: placebo; Drug: oxfendazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01584362

IND 113,628 (Other Identifier)

OXFEND-02, IND 113,628

Details and patient eligibility

About

This research is being done to learn about the safety in humans of a medicine that is already used in cows and pigs to treat worms. The medicine may be useful for people who have these or other worms. The medicine will be studied first in healthy people, who will be given a very small amount of the medicine once. If the smallest amount of medicine is found to be safe, a slightly higher amount will be given to a new group of volunteers. The highest amount that will be tested is similar to the amount given to animals. If the medicine can be given safely to healthy people in the planned amounts, a later study will be done in people who have worms to see if the medicine kills the worms.

Full description

The Phase I study proposed is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.3 to 30 mg/kg) in healthy volunteers. The dose will be increased approximately three-fold (one-half log) at each increment, and each cohort will comprise ten volunteers (eight drug, two placebo). Subjects will be monitored for three weeks after dosing, including monitoring the pharmacokinetics and metabolism of oxfendazole in blood and urine. Each new cohort will be dosed only after the three week safety data for the preceding group have been analyzed. If a clinically significant adverse event is observed, and if this event is possibly drug-related, an additional (and final) cohort of volunteers will repeat the highest tolerated dose of oxfendazole. Up to 70 volunteers (56 drug, 14 placebo) will complete the study.

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Height and weight within 25% of means for his/her gender and age.
• Willing to use two acceptable methods of contraception (approved oral, injectable, or implantable drug, IUD, diaphragm or condom with spermicidal jelly or foam, or sexual abstinence) for a minimum of one week before, and three weeks after dosing with oxfendazole; or surgically sterile.
• Able to give written informed consent.
• Able to provide a home phone number, and the name, address, and phone number of a person willing to assist making contact during the follow-up phase of the study.

Exclusion criteria

• Pregnant.
• Breast feeding.
• Chronic drug/alcohol user.
• Has clinically significant abnormalities in screening examinations
• Has history of sensitivity to related benzimidazole compounds (e.g. albendazole, mebendazole).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

0 participants in 7 patient groups, including a placebo group

oxfendazole 0.3

Experimental group

Description:

administration of a single oral 0.3mg/kg dose of oxfendazole

Treatment:

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

placebo comparator

Placebo Comparator group

Description:

administration of a single oral dose of placebo

Treatment:

Drug: placebo

oxfendazole 1.0

Experimental group

Description:

administration of a single oral 1.0 mg/kg dose of oxfendazole

Treatment:

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

oxfendazole 3.0

Experimental group

Description:

administration of a single oral 3 mg/kg dose of oxfendazole

Treatment:

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

oxfendazole 10

Experimental group

Description:

administration of a single oral 10 mg/kg dose of oxfendazole

Treatment:

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

oxfendazole 20

Experimental group

Description:

administration of a single oral 20 mg/kg dose of oxfendazole

Treatment:

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

oxfendazole 30

Experimental group

Description:

administration of a single oral 30 mg/kg dose of oxfendazole

Treatment:

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole

Drug: oxfendazole