NCT01584362

Single Ascending Dose Safety Study of Oxfendazole

Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis)

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Johns Hopkins Bloomberg School of Public Health · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Tenia Solium Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2012-04-25
• Last updated: 2016-08-30