Single Ascending Dose Safety Study of Oxfendazole

• Status: Withdrawn
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborators: School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos; Universidad Peruana Cayetano Heredia
• Treatments: Oxfendazole

Criteria

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).