Single Ascending Dose Safety Study of Oxfendazole

Tenia Solium Infection Clinical Trial

— OXFEND-02  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01584362
• Other study ID #: OXFEND-02, IND 113,628
• Secondary ID: IND 113,628
• Status: Withdrawn
• Phase: Phase 1
• First received: April 18, 2012
• Last updated: August 29, 2016
• Start date: August 2016
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neurocysticercosis
• Tenia Solium Infection

Intervention

Drug:
• oxfendazole
administration of a single oral 1.0 mg/kg dose of oxfendazole
• placebo
single oral dose of placebo
• oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
• oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
• oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
• oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
• oxfendazole
administration of a single oral 30 mg/kg dose of oxfendazole

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos, Universidad Peruana Cayetano Heredia

References & Publications (3)

Gonzales AE, Garcia HH, Gilman RH, Gavidia CM, Tsang VC, Bernal T, Falcon N, Romero M, Lopez-Urbina MT. Effective, single-dose treatment or porcine cysticercosis with oxfendazole. Am J Trop Med Hyg. 1996 Apr;54(4):391-4. — View Citation

Gonzalez AE, Falcon N, Gavidia C, Garcia HH, Tsang VC, Bernal T, Romero M, Gilman RH. Time-response curve of oxfendazole in the treatment of swine cysticercosis. Am J Trop Med Hyg. 1998 Nov;59(5):832-6. — View Citation

Gonzalez AE, Falcon N, Gavidia C, Garcia HH, Tsang VC, Bernal T, Romero M, Gilman RH. Treatment of porcine cysticercosis with oxfendazole: a dose-response trial. Vet Rec. 1997 Oct 18;141(16):420-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serious adverse events	Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.	up to three weeks after dosing	Yes
Secondary	adverse events	proportion of subjects who present with adverse events (AEs) related to ocfendazole	up to three weeks after dosing	Yes
Secondary	Pharmacokinetic Profile	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 (AUC8), Oral clearance (CL/F), Oral volume of distribution (Vz/F)	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	No