Single Ascending Dose Safety Study of Oxfendazole (OXFEND-02)
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ClinicalTrials.gov Identifier: NCT01584362 |
Recruitment Status :
Withdrawn
(study conducted under Clinical Trials Agreement as NIAID registration NCT02234570)
First Posted : April 25, 2012
Last Update Posted : August 30, 2016
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tenia Solium Infection | Drug: oxfendazole Drug: placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis) |
Study Start Date : | August 2016 |
Actual Primary Completion Date : | August 2016 |
Actual Study Completion Date : | August 2016 |
Arm | Intervention/treatment |
---|---|
Experimental: oxfendazole 0.3
administration of a single oral 0.3mg/kg dose of oxfendazole
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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
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Drug: placebo
single oral dose of placebo |
Experimental: oxfendazole 1.0
administration of a single oral 1.0 mg/kg dose of oxfendazole
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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
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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
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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
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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
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Drug: oxfendazole
administration of a single oral 30 mg/kg dose of oxfendazole |
- serious adverse events [ Time Frame: up to three weeks after dosing ]Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
- adverse events [ Time Frame: up to three weeks after dosing ]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 ]
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)
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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01584362
Principal Investigator: | Robert H Gilman, MD | Johns Hopkins University |
Responsible Party: | Robert Gilman, Professor, Johns Hopkins Bloomberg School of Public Health |
ClinicalTrials.gov Identifier: | NCT01584362 |
Other Study ID Numbers: |
OXFEND-02, IND 113,628 IND 113,628 ( Other Identifier: FDA ) |
First Posted: | April 25, 2012 Key Record Dates |
Last Update Posted: | August 30, 2016 |
Last Verified: | August 2016 |
Taenia solium neurocysticercosis oxfendazole |
clinical trial, phase 1 safety pharmacokinetics |
Neurocysticercosis Taeniasis Central Nervous System Helminthiasis Central Nervous System Parasitic Infections Central Nervous System Infections Infections Parasitic Diseases Cysticercosis Cestode Infections |
Helminthiasis Central Nervous System Diseases Nervous System Diseases Oxfendazole Anthelmintics Antiparasitic Agents Anti-Infective Agents Antinematodal Agents |