A Phase 1 interventional study of oxfendazole and placebo in Tenia Solium Infection, sponsored by Johns Hopkins Bloomberg School of Public Health. Withdrawn. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-30.
Sponsored by Johns Hopkins Bloomberg School of Public Health · Phase 1, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
Browse Neurocysticercosis studies →Johns Hopkins Bloomberg School of Public Health is the lead sponsor of 371 studies on the registry; 42 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Compared within Neurocysticercosis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Taeniasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
administration of a single oral 0.3mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral dose of placebo
Drug: placebo
administration of a single oral 1.0 mg/kg dose of oxfendazole
Drug: oxfendazole
administration of a single oral 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
Drug: oxfendazole
administration of a single oral 1.0 mg/kg dose of oxfendazole
single oral dose of placebo
administration of a single oral 3.0 mg/kg dose of oxfendazole
administration of a single oral 0.3 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
serious adverse events
Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
Time frame: up to three weeks after dosing
adverse events
proportion of subjects who present with adverse events (AEs) related to ocfendazole
Time frame: up to three weeks after dosing
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)
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
No study locations are listed for this record.
This study is withdrawn, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oxfendazole
Johns Hopkins Bloomberg School of Public Health →