Clinical Trial: Single Ascending Dose Safety Study of Oxfendazole

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis)

Brief 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 Summary: 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.
Sponsor: Johns Hopkins Bloomberg School of Public Health

Current Primary Outcome: serious adverse events [ Time Frame: up to three weeks after dosing ]

Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • adverse events [ Time Frame: up to three weeks after dosing ]
    proportion of subjects who present with adverse events (AEs) related to ocfendazole
  • Pharmacokinetic Profile [ Time Frame: blood samples are drawn at 17 time points up to three weeks and urine is collected at 7 intervals up to 72 hours after dosing ]

    The following PK parameters will be analyzed:

    Maximum plasma concentration (Cmax), Time to Cmax (Tmax), Elimination rate constant (Iz), Elimination half-life (T½), Area under the curve to the final sample (AUC0-t), Area under the curve to infinity (AUC∞), Oral clearance (CL/F), Oral volume of distribution (Vz/F)



Original Secondary Outcome: Same as current

Information By: Johns Hopkins Bloomberg School of Public Health

Dates:
Date Received: April 18, 2012
Date Started: August 2016
Date Completion:
Last Updated: August 29, 2016
Last Verified: August 2016