Single Ascending Dose Safety Study of Oxfendazole

NCT ID: NCT01584362

Last Updated: 2016-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2016-08-31

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

oxfendazole 0.3

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

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

placebo comparator

administration of a single oral dose of placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

single oral dose of placebo

oxfendazole 1.0

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

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

oxfendazole 3.0

administration of a single oral 3 mg/kg dose of oxfendazole

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

oxfendazole 10

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

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

oxfendazole 20

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

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

oxfendazole 30

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

Group Type: EXPERIMENTAL

oxfendazole

Intervention Type: DRUG

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

Interventions

oxfendazole

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

Intervention Type: DRUG

placebo

single oral dose of placebo

Intervention Type: DRUG

oxfendazole

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

Intervention Type: DRUG

oxfendazole

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

Intervention Type: DRUG

oxfendazole

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

Intervention Type: DRUG

oxfendazole

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

Intervention Type: DRUG

oxfendazole

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

Intervention Type: DRUG

Eligibility 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidad Peruana Cayetano Heredia

OTHER

Sponsor Role: collaborator

School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins Bloomberg School of Public Health

OTHER

Sponsor Role: lead

Responsible Party

Robert Gilman

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert H Gilman, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

References

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. doi: 10.1136/vr.141.16.420.

Reference Type: RESULT

PMID: 9364715 (View on PubMed)

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. doi: 10.4269/ajtmh.1996.54.391.

Reference Type: RESULT

PMID: 8615453 (View on PubMed)

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. doi: 10.4269/ajtmh.1998.59.832.

Reference Type: RESULT

PMID: 9840607 (View on PubMed)

Other Identifiers

IND 113,628

Identifier Type: OTHER

Identifier Source: secondary_id

OXFEND-02, IND 113,628

Identifier Type: -

Identifier Source: org_study_id