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

Primary Purpose

Tenia Solium Infection

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
oxfendazole
placebo
oxfendazole
oxfendazole
oxfendazole
oxfendazole
oxfendazole
Sponsored by
Johns Hopkins Bloomberg School of Public Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tenia Solium Infection focused on measuring Taenia solium, neurocysticercosis, oxfendazole, clinical trial, phase 1, safety, pharmacokinetics

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm Type

    Experimental

    Placebo Comparator

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    oxfendazole 0.3

    placebo comparator

    oxfendazole 1.0

    oxfendazole 3.0

    oxfendazole 10

    oxfendazole 20

    oxfendazole 30

    Arm Description

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

    administration of a single oral dose of placebo

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    adverse events
    proportion of subjects who present with adverse events (AEs) related to ocfendazole
    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 (AUC∞), Oral clearance (CL/F), Oral volume of distribution (Vz/F)

    Full Information

    First Posted
    April 18, 2012
    Last Updated
    August 29, 2016
    Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    Universidad Peruana Cayetano Heredia, School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01584362
    Brief Title
    Single Ascending Dose Safety Study of Oxfendazole
    Acronym
    OXFEND-02
    Official Title
    Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    study conducted under Clinical Trials Agreement as NIAID registration NCT02234570
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    August 2016 (Actual)
    Study Completion Date
    August 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Johns Hopkins Bloomberg School of Public Health
    Collaborators
    Universidad Peruana Cayetano Heredia, School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tenia Solium Infection
    Keywords
    Taenia solium, neurocysticercosis, oxfendazole, clinical trial, phase 1, safety, pharmacokinetics

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    oxfendazole 0.3
    Arm Type
    Experimental
    Arm Description
    administration of a single oral 0.3mg/kg dose of oxfendazole
    Arm Title
    placebo comparator
    Arm Type
    Placebo Comparator
    Arm Description
    administration of a single oral dose of placebo
    Arm Title
    oxfendazole 1.0
    Arm Type
    Experimental
    Arm Description
    administration of a single oral 1.0 mg/kg dose of oxfendazole
    Arm Title
    oxfendazole 3.0
    Arm Type
    Experimental
    Arm Description
    administration of a single oral 3 mg/kg dose of oxfendazole
    Arm Title
    oxfendazole 10
    Arm Type
    Experimental
    Arm Description
    administration of a single oral 10 mg/kg dose of oxfendazole
    Arm Title
    oxfendazole 20
    Arm Type
    Experimental
    Arm Description
    administration of a single oral 20 mg/kg dose of oxfendazole
    Arm Title
    oxfendazole 30
    Arm Type
    Experimental
    Arm Description
    administration of a single oral 30 mg/kg dose of oxfendazole
    Intervention Type
    Drug
    Intervention Name(s)
    oxfendazole
    Intervention Description
    administration of a single oral 1.0 mg/kg dose of oxfendazole
    Intervention Type
    Drug
    Intervention Name(s)
    placebo
    Intervention Description
    single oral dose of placebo
    Intervention Type
    Drug
    Intervention Name(s)
    oxfendazole
    Intervention Description
    administration of a single oral 3.0 mg/kg dose of oxfendazole
    Intervention Type
    Drug
    Intervention Name(s)
    oxfendazole
    Intervention Description
    administration of a single oral 0.3 mg/kg dose of oxfendazole
    Intervention Type
    Drug
    Intervention Name(s)
    oxfendazole
    Intervention Description
    administration of a single oral 10 mg/kg dose of oxfendazole
    Intervention Type
    Drug
    Intervention Name(s)
    oxfendazole
    Intervention Description
    administration of a single oral 20 mg/kg dose of oxfendazole
    Intervention Type
    Drug
    Intervention Name(s)
    oxfendazole
    Intervention Description
    administration of a single oral 30 mg/kg dose of oxfendazole
    Primary Outcome Measure Information:
    Title
    serious adverse events
    Description
    Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
    Time Frame
    up to three weeks after dosing
    Secondary Outcome Measure Information:
    Title
    adverse events
    Description
    proportion of subjects who present with adverse events (AEs) related to ocfendazole
    Time Frame
    up to three weeks after dosing
    Title
    Pharmacokinetic Profile
    Description
    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)
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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).
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Robert H Gilman, MD
    Organizational Affiliation
    Johns Hopkins University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    9364715
    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. doi: 10.1136/vr.141.16.420.
    Results Reference
    result
    PubMed Identifier
    8615453
    Citation
    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.
    Results Reference
    result
    PubMed Identifier
    9840607
    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. doi: 10.4269/ajtmh.1998.59.832.
    Results Reference
    result

    Learn more about this trial

    Single Ascending Dose Safety Study of Oxfendazole

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