Tenia Solium InfectionPhase 1OXFEND-02NCT01584362
Single Ascending Dose Safety Study of Oxfendazole
A Phase 1 study testing oxfendazole in people with Tenia Solium Infection, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Tenia Solium Infection
- What is being tested?
- oxfendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2016to Aug 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: 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.
Read the 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.
- Conditions
- Tenia Solium Infection
- Being tested
- oxfendazole, placebo
- Keywords
- Taenia solium, neurocysticercosis, oxfendazole, clinical trial, phase 1, safety, pharmacokinetics
- Medical subject headings
- Taeniasis, Neurocysticercosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxfendazoleDrug
administration of a single oral 1.0 mg/kg dose of oxfendazole
placeboDrug
single oral dose of placebo
oxfendazoleDrug
administration of a single oral 3.0 mg/kg dose of oxfendazole
oxfendazoleDrug
administration of a single oral 0.3 mg/kg dose of oxfendazole
oxfendazoleDrug
administration of a single oral 10 mg/kg dose of oxfendazole
oxfendazoleDrug
administration of a single oral 20 mg/kg dose of oxfendazole
oxfendazoleDrug
administration of a single oral 30 mg/kg dose of oxfendazole
| Study group | Role | What they receive |
|---|---|---|
| oxfendazole 0.3 | Experimental | administration of a single oral 0.3mg/kg dose of oxfendazole Receives: Drug: oxfendazole |
| placebo comparator | Placebo comparator | administration of a single oral dose of placebo Receives: Drug: placebo |
| oxfendazole 1.0 | Experimental | administration of a single oral 1.0 mg/kg dose of oxfendazole Receives: Drug: oxfendazole |
| oxfendazole 3.0 | Experimental | administration of a single oral 3 mg/kg dose of oxfendazole Receives: Drug: oxfendazole |
| oxfendazole 10 | Experimental | administration of a single oral 10 mg/kg dose of oxfendazole Receives: Drug: oxfendazole |
| oxfendazole 20 | Experimental | administration of a single oral 20 mg/kg dose of oxfendazole Receives: Drug: oxfendazole |
| oxfendazole 30 | Experimental | administration of a single oral 30 mg/kg dose of oxfendazole Receives: Drug: oxfendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
serious adverse events
Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
Measured: up to three weeks after dosing
Secondary outcomes (2)
adverse events
proportion of subjects who present with adverse events (AEs) related to ocfendazole
Measured: 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)
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2012 (estimated)
- Study startAug 2016
- Primary completionAug 2016
- Study completionAug 2016
Why it stopped: study conducted under Clinical Trials Agreement as NIAID registration NCT02234570
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Tenia Solium InfectionStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos
- Responsible party
- Principal investigator, Robert Gilman, Johns Hopkins Bloomberg School of Public Health
- Investigators
- Robert H Gilman, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01584362
- Sponsor's protocol ID
- OXFEND-02, IND 113,628
- Other IDs
- IND 113,628
- Acronym
- OXFEND-02
- Status last verified
- Aug 2016
- First submitted
- 18 Apr 2012
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 9364715Gonzales 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.
PubMed 8615453Gonzalez 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.
PubMed 9840607
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Oxfendazole (Toward the Treatment of Neurocysticercosis)
- ClinicalTrials.gov ID
- NCT01584362
- Acronym / sponsor ID
- OXFEND-02 / OXFEND-02, IND 113,628
- Conditions
- Tenia Solium Infection
- Keywords
- Taenia solium, neurocysticercosis, oxfendazole, clinical trial, phase 1, safety, pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: study conducted under Clinical Trials Agreement as NIAID registration NCT02234570
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- Universidad Peruana Cayetano Heredia, School of Veterinary Medicine, Universidad Nacional Mayor de San Marcos
- Study start
- Aug 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 25 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| oxfendazole 0.3 | Experimental | Drug: oxfendazoleadministration of a single oral 0.3mg/kg dose of oxfendazole |
| placebo comparator | Placebo comparator | Drug: placeboadministration of a single oral dose of placebo |
| oxfendazole 1.0 | Experimental | Drug: oxfendazoleadministration of a single oral 1.0 mg/kg dose of oxfendazole |
| oxfendazole 3.0 | Experimental | Drug: oxfendazoleadministration of a single oral 3 mg/kg dose of oxfendazole |
| oxfendazole 10 | Experimental | Drug: oxfendazoleadministration of a single oral 10 mg/kg dose of oxfendazole |
| oxfendazole 20 | Experimental | Drug: oxfendazoleadministration of a single oral 20 mg/kg dose of oxfendazole |
| oxfendazole 30 | Experimental | Drug: oxfendazoleadministration of a single oral 30 mg/kg dose of oxfendazole |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxfendazoleadministration of a single oral 1.0 mg/kg dose of oxfendazole | Drug | oxfendazole 1.0 |
| placebosingle oral dose of placebo | Drug | placebo comparator |
| oxfendazoleadministration of a single oral 3.0 mg/kg dose of oxfendazole | Drug | oxfendazole 3.0 |
| oxfendazoleadministration of a single oral 0.3 mg/kg dose of oxfendazole | Drug | oxfendazole 0.3 |
| oxfendazoleadministration of a single oral 10 mg/kg dose of oxfendazole | Drug | oxfendazole 10 |
| oxfendazoleadministration of a single oral 20 mg/kg dose of oxfendazole | Drug | oxfendazole 20 |
| oxfendazoleadministration of a single oral 30 mg/kg dose of oxfendazole | Drug | oxfendazole 30 |
Primary outcome
serious adverse events
Time frame: up to three weeks after dosing
Proportion of patients who present with serious adverse events (SAEs) related to oxfendazole.
2 secondary outcomes
adverse events
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2016.
- Results publication: PubMed 9364715Gonzalez 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 publication: PubMed 8615453Gonzales 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 publication: PubMed 9840607Gonzalez 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.
Related trials for Tenia Solium Infection
RecruitingObservational study
Natural History of Treated Neurocysticercosis and Long-Term Outcomes
Cysticercosis, Neurocysticercosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert H Gilman, MD principal investigator
Johns Hopkins University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing oxfendazole in people with Tenia Solium Infection, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serious adverse events (time frame: up to three weeks after dosing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01584362, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2016.