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

August 29, 2016 updated by: Robert Gilman, Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: oxfendazole 0.3
administration of a single oral 0.3mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 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
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 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 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 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 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 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 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 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 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 3.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 0.3 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 10 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 20 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 30 mg/kg dose of oxfendazole

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
serious adverse events
Time Frame: up to three weeks after dosing
Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
up to three weeks after dosing

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
adverse events
Time Frame: up to three weeks after dosing
proportion of subjects who present with adverse events (AEs) related to ocfendazole
up to three weeks after dosing
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

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)
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Universidad Peruana Cayetano Heredia
School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Robert H Gilman, MD, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 18, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 24, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OXFEND-02, IND 113,628
  • IND 113,628 (OTHER: FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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