NeurocysticercosisPhase 1NCT02234570
Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
A Phase 1 study testing Oxfendazole in people with Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The objectives of the Phase I study are to evaluate the safety and tolerance of increasing single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Neurocysticercosis
- What is being tested?
- Oxfendazole
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Nov 2014to 24 Nov 2015
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 1. Males and females of non-childbearing potential between the ages of 18 and 45 years, inclusive. Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels. 2. In good health, as judged by the investigator and determined by vital signs Temperature < 38 degrees Celsius, heart rate </=100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg and > 89 mmHg, diastolic blood pressure </=90 mmHg and >/= 60 mm Hg, medical history and a targeted physical examination. BMI >/=18 and </= 35. Athletically trained subjects with a pulse >/= 45 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator. 3. Acceptable screening laboratories Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values below the normal range are acceptable). Random blood glucose must be <140. Urine dipstick testing must be negative for glucose and negative or trace for protein. The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be performed for individuals suspected of having indeterminate antibody testing. 4. Male participants must be willing to ensure use of condoms and spermicides for 4 months after study drug administration. 5. Provide written informed consent before initiation of any study procedures. 6. Willing to be available for all study-required procedures, and visits for the duration of the study. 7. Able to provide a home phone number, and the name, address, and/or email of a person willing to assist with making contact during the follow-up phase of the study.
Who cannot join
- 1. History of residing for 6 or more months in regions with endemic cysticercosis as determined by the principal investigator or a designated study physician. 2. Breastfeeding females. 3. Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before administration of study drug (subject may be rescheduled). 4. Chronic or acute medical disorder Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal or other system, such that in the opinion of the investigator participation in the study creates additional risk to the subject, or to the validity of the study. 5. Use of chronic systemic medications Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment (please see section 5.6 for instructions on medication use during the study).Topical medications, nasal steroids are permitted throughout the study. Use of the prescription medications used less than once per week on average are permitted for enrollment (see section 5.6 for instructions on medication use during the study). If the subject has taken a short term prescription medication within the past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30 days have elapsed since the last dose 6. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole). 7. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt. 8. A history of treatment for any other psychiatric disorder in the past 3 years. Past treatment for ADHD does not exclude participants from enrollment as long as the medications have been discontinued for a minimum of 3 months and symptoms are well controlled. 9. Received an experimental agent within 1 month before administration of study drug or expect to receive an experimental agent during the 15-day study period. Vaccine, drug, biologic, device, blood product, or medication. 10. Any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or that may interfere with successful completion of the study. 11. A history of alcohol consumption or any illicit drug use†, or history of substance abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours prior to enrollment through day 15. Greater than 7 alcoholic drinks per week. †Other than occasional marijuana use (less than once per week for the past 60 days is acceptable). #Alcohol or illicit drugs within the past 3 years. 12. History of chronic tobacco use in the past 60 days. A history of occasional tobacco use (less than 1 pack per week on average) is acceptable. Individuals will be counseled to abstain from use of tobacco and marijuana from screening through day 15.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa - Vaccine Research and Education Unit
Iowa City, Iowa, 52242-2600
About this study
Official title: A Randomized, Double-Blind Placebo-Controlled Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
The objectives of the Phase I study are to evaluate the safety and tolerance of increasing single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The description of agent used is single oral dose of an aqueous suspension of oxfendazole, a benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two week safety data for the preceding group have been reviewed. If a clinically significant AE is observed, and if this event is drug-related the safety monitoring committee will be convened to determine whether the study should continue.
Read the detailed description
This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages 18-45 volunteers recruited from one site will participate in this study. The study duration is approximately 18 months with subject participation of 2 weeks. The primary objective assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be monitored 48 hours for adverse events prior to completing enrollment of the remaining 8 subjects in the group.
- Conditions
- Neurocysticercosis
- Being tested
- Oxfendazole, Placebo
- Keywords
- neurocysticercosis, pork tapeworm, Taenia solium
- Medical subject headings
- Neurocysticercosis, Taeniasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxfendazoleDrug
A benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7.
PlaceboOther
Normal Saline administered with an oral dosing syringe. Group 1- Group 6
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | N=8 subjects receive single oral dose 0.5mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
| Group 2 | Experimental | N=8 subjects receive single oral dose 1mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
| Group 3 | Experimental | N=8 subjects receive single oral dose 3mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
| Group 4 | Experimental | N=8 subjects receive single oral dose 7.5mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
| Group 5 | Experimental | N=8 subjects receive single oral dose 15mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
| Group 6 | Experimental | N=8 subjects receive single oral dose 30mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
| Group 7 | Experimental | N=8 subjects receive single oral dose 60mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo Receives: Drug: Oxfendazole; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.
All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as "there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."
Measured: Within 14 Days of first dose
Secondary outcomes (8)
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole
AUC(0-infinity) was defined as the total area under the concentration-time curve from dosing (time 0) taken to the limit as the end time becomes arbitrarily large. AUC(0-infinity) and was calculated by adding AUC(0-last) to an extrapolated value equal to the last measured concentration greater than the lower limit of quantification of the bioanalytical assay divided by the terminal phase elimination rate constant (Ke) computed from concentrations that were measured using a validated HPLCMS/MS method
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma
Cmax is defined as the maximum observed drug concentration observed in plasma over all PK sample concentrations computed from concentrations that were measured using a validated HPLC-MS/MS method.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Plasma Concentrations of Oxfendazole Fenbendazole
Concentrations of oxfendazole fenbendazole in plasma were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Measured: Day 1-Day15
Plasma Concentrations of Oxfendazole Sulfone
Concentrations of oxfendazole sulfone in plasma were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Measured: Day 1-Day15
Terminal Elimination Half-life (t1/2) of Oxfendazole
The apparent terminal elimination half-life (t1/2) was defined as the time required for the drug concentration to decrease by a factor of one-half in the terminal phase computed from concentrations that were measured using a validated HPLCMS/MS method.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Time of Maximum Observed Concentration (Tmax) of Oxfendazole
Tmax was defined as the time at which the maximum concentration (Cmax) occurs in plasma computed from concentrations that were measured using a validated HPLCMS/MS method.
Measured: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Urine Concentrations of Oxfendazole Fenbendazole
Concentrations of oxfendazole fenbendazole in urine were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Measured: Day 1-Day 15
Urine Concentrations of Oxfendazole Sulfone
Concentrations of oxfendazole sulfone in urine were measured using a validated HPLCMS/MS method. Concentrations <LLOQ (2 ng/mL) set to LLOQ/2 if after 1st =LLOQ concentration or 0 otherwise for calculating summary statistics.
Measured: Day 1-Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start17 Nov 2014
- Primary completion24 Nov 2015
- Study completion24 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NeurocysticercosisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234570
- Sponsor's protocol ID
- 12-0053
- Status last verified
- 5 Dec 2019
- First submitted
- 28 Aug 2014
- Last updated
- 2 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
An G, Murry DJ, Gajurel K, Bach T, Deye G, Stebounova LV, Codd EE, Horton J, Gonzalez AE, Garcia HH, Ince D, Hodgson-Zingman D, Nomicos EYH, Conrad T, Kennedy J, Jones W, Gilman RH, Winokur P. Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Volunteers: a Randomized, Placebo-Controlled First-in-Human Single-Dose Escalation Study. Antimicrob Agents Chemother. 2019 Mar 27;63(4):e02255-18. doi: 10.1128/AAC.02255-18. Print 2019 Apr.
PubMed 30745383
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Placebo-Controlled Phase I Trial Evaluating the Safety and Pharmacokinetics of Oxfendazole
- ClinicalTrials.gov ID
- NCT02234570
- Acronym / sponsor ID
- 12-0053
- Conditions
- Neurocysticercosis
- Keywords
- neurocysticercosis, pork tapeworm, Taenia solium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 24 Nov 2015 (actual)
- Study completion
- 24 Nov 2015 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objectives of the Phase I study are to evaluate the safety and tolerance of increasing single oral doses of oxfendazole in healthy volunteers.The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. The description of agent used is single oral dose of an aqueous suspension of oxfendazole, a benzimidazole carbamate antiparasitic drug. Each new cohort will be dosed only after the two week safety data for the preceding group have been reviewed. If a clinically significant AE is observed, and if this event is drug-related the safety monitoring committee will be convened to determine whether the study should continue.
Detailed description
This Phase I study is a randomized, double-blind, placebo-controlled evaluation of the safety and pharmacokinetics of escalating single oral doses of oxfendazole (0.5 to 60 mg/kg) in healthy volunteers. Up to 70 healthy males and females (non-chldbearing potential), ages 18-45 volunteers recruited from one site will participate in this study. The study duration is approximately 18 months with subject participation of 2 weeks. The primary objective assess the safety and tolerability of oxfendazole in healthy adults. The secondary objectives assess the pharmacokinetic profile of oxfendazole and assess the metabolism of oxfendazole. Two sentinel subjects will receive the study product (1 drug/1 placebo) in each group and be monitored 48 hours for adverse events prior to completing enrollment of the remaining 8 subjects in the group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 0.5mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo |
| Group 2 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 1mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo |
| Group 3 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 3mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo |
| Group 4 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 7.5mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo |
| Group 5 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 15mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo |
| Group 6 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 30mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo |
| Group 7 | Experimental | Drug: Oxfendazole, Other: PlaceboN=8 subjects receive single oral dose 60mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 1. Males and females of non-childbearing potential between the ages of 18 and 45 years, inclusive. Surgically sterile via tubal ligation, bilateral oophorectomy or hysterectomy or who have been postmenopausal for >/=1 year confirmed by LH and FSH levels. 2. In good health, as judged by the investigator and determined by vital signs Temperature < 38 degrees Celsius, heart rate </=100 bpm and > 50 bpm, systolic blood pressure </= 140 mmHg and > 89 mmHg, diastolic blood pressure </=90 mmHg and >/= 60 mm Hg, medical history and a targeted physical examination. BMI >/=18 and </= 35. Athletically trained subjects with a pulse >/= 45 may be enrolled at the discretion of the principal investigator or designated licensed clinical investigator. 3. Acceptable screening laboratories Hemoglobin, white blood cell (WBC) count, neutrophil, eosinophil and platelet counts within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (for eosinophil count, AST, ALT, creatinine, and total bilirubin values below the normal range are acceptable). Random blood glucose must be <140. Urine dipstick testing must be negative for glucose and negative or trace for protein. The following serology tests must be negative: HIV 1/2 antibody, hepatitis B surface antigen (HBsAg), and hepatitis C virus (HCV) antibody. HIV and hepatitis C viral load PCR testing may be performed for individuals suspected of having indeterminate antibody testing. 4. Male participants must be willing to ensure use of condoms and spermicides for 4 months after study drug administration. 5. Provide written informed consent before initiation of any study procedures. 6. Willing to be available for all study-required procedures, and visits for the duration of the study. 7. Able to provide a home phone number, and the name, address, and/or email of a person willing to assist with making contact during the follow-up phase of the study.
Key exclusion criteria (1 listed)
- 1. History of residing for 6 or more months in regions with endemic cysticercosis as determined by the principal investigator or a designated study physician. 2. Breastfeeding females. 3. Body temperature >/=100.4 degrees Fahrenheit (>/=38.0 degrees Celsius) or acute illness within 3 days before administration of study drug (subject may be rescheduled). 4. Chronic or acute medical disorder Disorders of the cardiac, pulmonary, liver, kidney, neurologic, gastrointestinal or other system, such that in the opinion of the investigator participation in the study creates additional risk to the subject, or to the validity of the study. 5. Use of chronic systemic medications Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment (please see section 5.6 for instructions on medication use during the study).Topical medications, nasal steroids are permitted throughout the study. Use of the prescription medications used less than once per week on average are permitted for enrollment (see section 5.6 for instructions on medication use during the study). If the subject has taken a short term prescription medication within the past 30 days (e.g. an antibiotic), they should be postponed from enrollment until 30 days have elapsed since the last dose 6. Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole). 7. A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt. 8. A history of treatment for any other psychiatric disorder in the past 3 years. Past treatment for ADHD does not exclude participants from enrollment as long as the medications have been discontinued for a minimum of 3 months and symptoms are well controlled. 9. Received an experimental agent within 1 month before administration of study drug or expect to receive an experimental agent during the 15-day study period. Vaccine, drug, biologic, device, blood product, or medication. 10. Any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury, render them unable to meet the requirements of the protocol, or that may interfere with successful completion of the study. 11. A history of alcohol consumption or any illicit drug use†, or history of substance abuse#. Individuals must agree to abstain from drug or alcohol use for 48 hours prior to enrollment through day 15. Greater than 7 alcoholic drinks per week. †Other than occasional marijuana use (less than once per week for the past 60 days is acceptable). #Alcohol or illicit drugs within the past 3 years. 12. History of chronic tobacco use in the past 60 days. A history of occasional tobacco use (less than 1 pack per week on average) is acceptable. Individuals will be counseled to abstain from use of tobacco and marijuana from screening through day 15.
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 |
|---|---|---|
| OxfendazoleA benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7. | Drug | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
| PlaceboNormal Saline administered with an oral dosing syringe. Group 1- Group 6 | Other | Group 1, Group 2, Group 3, Group 4, Group 5, Group 6, Group 7 |
Primary outcome
Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose.
Time frame: Within 14 Days of first dose
All adverse events, defined as any untoward medical occurrence regardless of its causal relationship to the study treatment, were collected for 14 days after dosing. The PI then determined relatedness to the study drug. Related was defined as "there is a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event."
8 secondary outcomes
Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Plasma Concentrations of Oxfendazole Fenbendazole
Time frame: Day 1-Day15
Plasma Concentrations of Oxfendazole Sulfone
Time frame: Day 1-Day15
Terminal Elimination Half-life (t1/2) of Oxfendazole
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Time of Maximum Observed Concentration (Tmax) of Oxfendazole
Time frame: 0, 1, 2, 4, 6, 8, 10, 12, 24, 48, 72, 120, 168, 336 hours post-dose
Urine Concentrations of Oxfendazole Fenbendazole
Time frame: Day 1-Day 15
Urine Concentrations of Oxfendazole Sulfone
Time frame: Day 1-Day 15
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 30745383An G, Murry DJ, Gajurel K, Bach T, Deye G, Stebounova LV, Codd EE, Horton J, Gonzalez AE, Garcia HH, Ince D, Hodgson-Zingman D, Nomicos EYH, Conrad T, Kennedy J, Jones W, Gilman RH, Winokur P. Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Volunteers: a Randomized, Placebo-Controlled First-in-Human Single-Dose Escalation Study. Antimicrob Agents Chemother. 2019 Mar 27;63(4):e02255-18. doi: 10.1128/AAC.02255-18. Print 2019 Apr.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Oxfendazole in people with Neurocysticercosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose. (time frame: Within 14 Days of first dose). 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 NCT02234570, which also lists 1 linked publication.
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 2 Nov 2020.