Single Ascending Dose Safety Study of Oxfendazole

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.

Conditions

• Tenia Solium Infection

Interventions

DRUG

oxfendazole

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

DRUG

placebo

single oral dose of placebo

DRUG

oxfendazole

administration of a single oral 3.0 mg/kg dose of oxfendazole

DRUG

oxfendazole

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

DRUG

oxfendazole

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

DRUG

oxfendazole

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

DRUG

oxfendazole

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

Sponsors & Collaborators

• Universidad Peruana Cayetano Heredia

  collaborator OTHER

• School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos

  collaborator UNKNOWN

• Johns Hopkins Bloomberg School of Public Health

  lead OTHER

Principal Investigators

• Robert H Gilman, MD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-08-31

Primary Completion

2016-08-31

Completion

2016-08-31