Single Ascending Dose Safety Study of Oxfendazole

NCT01584362 | Withdrawn Phase 1

• 2 other identifiers: OXFEND-02, IND 113,628IND 113,628
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tenia Solium Infection

Keywords

Taenia solium; neurocysticercosis; oxfendazole; clinical trial, phase 1; safety; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• serious adverse events

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

  up to three weeks after dosing

Secondary Outcomes (2)

• adverse events

  up to three weeks after dosing

• Pharmacokinetic Profile

  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

Study Arms (7)

oxfendazole 0.3

EXPERIMENTAL

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

Drug: oxfendazole

placebo comparator

PLACEBO COMPARATOR

administration of a single oral dose of placebo

Drug: placebo

oxfendazole 1.0

EXPERIMENTAL

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

Drug: oxfendazole

oxfendazole 3.0

EXPERIMENTAL

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

Drug: oxfendazole

oxfendazole 10

EXPERIMENTAL

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

Drug: oxfendazole

oxfendazole 20

EXPERIMENTAL

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

Drug: oxfendazole

oxfendazole 30

EXPERIMENTAL

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

Drug: oxfendazole

Interventions

oxfendazole DRUG

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

oxfendazole 1.0

placebo DRUG

single oral dose of placebo

placebo comparator

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• Universidad Peruana Cayetano Heredia: collaborator
• School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos: collaborator

Related Publications (3)

• 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.

  PMID: 9364715 RESULT

• 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.

  PMID: 8615453 RESULT

• 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.

  PMID: 9840607 RESULT

MeSH Terms

Conditions

Taeniasis; Neurocysticercosis

Interventions

oxfendazole

Condition Hierarchy (Ancestors)

Cestode Infections; Helminthiasis; Parasitic Diseases; Infections; Central Nervous System Helminthiasis; Central Nervous System Parasitic Infections; Central Nervous System Infections; Cysticercosis; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Robert H Gilman, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 18, 2012
• First Posted: April 25, 2012
• Study Start: August 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: August 30, 2016

Record last verified: 2016-08