Single Ascending Dose Safety Study of Oxfendazole (OXFEND-02)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified March 2014 by Johns Hopkins Bloomberg School of Public Health
Sponsor:
Collaborators:
Universidad Peruana Cayetano Heredia
School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos
Information provided by (Responsible Party):
Robert Gilman, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier:
NCT01584362
First received: April 18, 2012
Last updated: March 10, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Tenia Solium Infection
Drug: oxfendazole
Drug: placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis)

Resource links provided by NLM:


Further study details as provided by Johns Hopkins Bloomberg School of Public Health:

Primary Outcome Measures:
  • serious adverse events [ Time Frame: up to three weeks after dosing ] [ Designated as safety issue: Yes ]
    Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.


Secondary Outcome Measures:
  • adverse events [ Time Frame: up to three weeks after dosing ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

    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)



Estimated Enrollment: 70
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: oxfendazole 0.3
administration of a single oral 0.3mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Placebo Comparator: placebo comparator
administration of a single oral dose of placebo
Drug: placebo
single oral dose of placebo
Experimental: oxfendazole 1.0
administration of a single oral 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 1.0 mg/kg dose of oxfendazole
Experimental: oxfendazole 3.0
administration of a single oral 3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Experimental: oxfendazole 10
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Experimental: oxfendazole 20
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Experimental: oxfendazole 30
administration of a single oral 30 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 mg/kg dose of oxfendazole

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01584362

Contacts
Contact: Robert H Gilman, MD (410) 614-3959 rgilman@jhsph.edu

Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
Universidad Peruana Cayetano Heredia
School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos
Investigators
Principal Investigator: Robert H Gilman, MD Johns Hopkins University
  More Information

Publications:
Responsible Party: Robert Gilman, Professor, Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT01584362     History of Changes
Other Study ID Numbers: OXFEND-02, IND 113,628, IND 113,628
Study First Received: April 18, 2012
Last Updated: March 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Johns Hopkins Bloomberg School of Public Health:
Taenia solium
neurocysticercosis
oxfendazole
clinical trial, phase 1
safety
pharmacokinetics

Additional relevant MeSH terms:
Neurocysticercosis
Taeniasis
Central Nervous System Diseases
Central Nervous System Helminthiasis
Central Nervous System Infections
Central Nervous System Parasitic Infections
Cestode Infections
Cysticercosis
Helminthiasis
Nervous System Diseases
Parasitic Diseases
Oxfendazole
Anthelmintics
Anti-Infective Agents
Antinematodal Agents
Antiparasitic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014