Helminthic InfectionPhase 1NCT03035760
Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
A Phase 1 study testing Oxfendazole in people with Helminthic Infection, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant women aged 18-45 followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a single dose 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
- Helminthic Infection
- What is being tested?
- Oxfendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2017to 23 Apr 2019
- 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
- Males and nonpregnant females between the ages of 18 and 45 years, inclusive.
- Women of childbearing potential* must agree to practice adequate contraception** for the 28-day period before Day 0 through 4 months after the last dose of study medication.
- A woman is considered of childbearing potential unless surgically sterile (tubal ligation, bilateral oophorectomy, or hysterectomy) or post-menopausal (=1 year).
- Acceptable birth control methods include but are not limited to: abstinence from sexual intercourse with men; monogamous relationship with a vasectomized partner; double-barrier methods (condoms, diaphragms, spermicides); intrauterine devices; and licensed hormonal methods.
- In good health, as judged by the investigator and determined by vital signs*
- Temperature < 38°C, 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. Acceptable screening laboratories: Hemoglobin, white blood cell (WBC) count, neutrophil, and platelet counts, INR and PTT within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (creatinine 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.
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- Male participants must be willing to ensure use of condoms and spermicides for 4 months after the last dose study medication.
- Provide written informed consent before initiation of any study procedures.
- Willing to be available for all study-required procedures, and visits for the duration of the study.
- Individuals must agree to abstain from drug or alcohol use for 48 hours prior to enrollment through day 10 or 14.
- 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
- Pregnant women, women who are planning to become pregnant in the next 4 months, or women who are breastfeeding.
- Body temperature >=100.4°F (>=38.0°C) or acute illness within 3 days before administration of study drug (subject may be rescheduled).
- 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.
- Use of chronic systemic medications* *Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment Topical medications, nasal steroids are permitted throughout the study. Use of prescription medications used less than once per week on average are permitted for enrollment. 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.
- Has history of sensitivity to related benzimidazole compounds (e.g., albendazole, mebendazole).
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- A diagnosis of schizophrenia, bipolar disease, or history of hospitalization for a psychiatric condition or previous suicide attempt.
- 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.
- Received an experimental agent* within 1 month before administration of study drug or expect to receive an experimental agent during the 10 or 14-day study period.
- Vaccine, drug, biologic, device, blood product, or medication.
- Any condition that would, in the opinion of the investigator, interfere with the study.*
- This includes any condition that would 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.
- A history of heavy alcohol* or illicit drug use**, or history of substance abuse#.
- On average, 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.
- 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 10 or 14.
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 Phase 1 Open Label, Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant women aged 18-45 followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or following a high fat meal. The study duration will be approximately 12 months with each subject participation lasting approximately 6 weeks. In the multiple ascending dose evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and monitored for 7 days from the time of the first dose for predefined adverse events. If there are no predefined safety events, a second sentinel subject will be enrolled and followed for a total of 7 days. If there are no predefined safety signals identified for either of these two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight subjects have completed the 10 day follow up period, an electronic safety review of the electronic data will be performed. If none of the predefined safety events have occurred DMID will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined adverse events prior to enrolling the remaining subjects in the group. After the 10 day follow up period has been completed for group 2, an electronic safety review will be completed and if no predefined events have occurred two sequential subjects (one at a time with 7 days between each subject) will be enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined safety events prior to enrolling the remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled into the single dose cross over group where half of the subjects will initially receive a single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then cross over to receive a single dose following a high fat breakfast or fasting period (water is permitted). All subjects will have received a dose of oxfendazole following both a fasting period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole administered daily for five days; and 2) To assess the safety of oxfendazole administered as a single dose with or without food.
Read the detailed description
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant women aged 18-45 followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or following a high fat meal. The study duration will be approximately 12 months with each subject participation lasting approximately 6 weeks. In the multiple ascending dose evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and monitored for 7 days from the time of the first dose for predefined adverse events. If there are no predefined safety events, a second sentinel subject will be enrolled and followed for a total of 7 days. If there are no predefined safety signals identified for either of these two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight subjects have completed the 10 day follow up period, an electronic safety review of the electronic data will be performed. If none of the predefined safety events have occurred DMID will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined adverse events prior to enrolling the remaining subjects in the group. After the 10 day follow up period has been completed for group 2, an electronic safety review will be completed and if no predefined events have occurred two sequential subjects (one at a time with 7 days between each subject) will be enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined safety events prior to enrolling the remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled into the single dose cross over group where half of the subjects will initially receive a single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then cross over to receive a single dose following a high fat breakfast or fasting period (water is permitted). All subjects will have received a dose of oxfendazole following both a fasting period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole administered daily for five days; and 2) To assess the safety of oxfendazole administered as a single dose with or without food. The secondary objectives are: 1) To define the multi-dose kinetics of oxfendazole; and 2) To determine the effect of food on the kinetics of oxfendazole.
- Conditions
- Helminthic Infection
- Being tested
- Oxfendazole
- Keywords
- Helminths, Oxfendazole, Pharmacokinetics, Safety
- Medical subject headings
- Trematode Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxfendazoleDrug
methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, is a broad spectrum benzimidazole antihelminthic. It is the sulphoxide metabolite of fenbendazole.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 3 mg/kg orally once daily for 5 days (n = 8) Receives: Drug: Oxfendazole |
| 2 | Experimental | 7.5 mg/kg orally once daily for 5 days (n = 8) Receives: Drug: Oxfendazole |
| 3 | Experimental | 15 mg/kg orally once daily for 5 days (n = 8) Receives: Drug: Oxfendazole |
| 4 | Experimental | 3 mg/kg orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8 Receives: Drug: Oxfendazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3
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: Day 1 through Day 10
Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4
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: Day 1 through Day 14
Secondary outcomes (8)
Area Under the Concentration Time-curve for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3
AUCtau was defined as the total area under the concentration-time curve from dosing to the end of the 24-hour dosing interval for Dose 1 and Dose 5. AUCtau was calculated using the Linear Up Log Down calculation method.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4
AUClast was defined as the area under the concentration-time curve from dosing to the time of the last measured concentration of that dosing period greater than the lower limit of quantification of the bioanalytical assay. AUClast was calculated using the Linear Up Log Down calculation method.
Measured: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3
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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4
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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3
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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4
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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3
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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4
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, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start12 May 2017
- Primary completion23 Apr 2018
- Study completion23 Apr 2019
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 Helminthic InfectionStudies 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035760
- Sponsor's protocol ID
- 16-0005
- Other IDs
- HHSN272201300020I
- Status last verified
- 19 Jul 2017
- First submitted
- 26 Jan 2017
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bach T, Galbiati S, Kennedy JK, Deye G, Nomicos EYH, Codd EE, Garcia HH, Horton J, Gilman RH, Gonzalez AE, Winokur P, An G. Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Adults in an Open-Label Phase 1 Multiple Ascending Dose and Food Effect Study. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e01018-20. doi: 10.1128/AAC.01018-20. Print 2020 Oct 20.
PubMed 32816721
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Open Label, Multiple Ascending Dose Study of Oxfendazole in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03035760
- Acronym / sponsor ID
- 16-0005
- Conditions
- Helminthic Infection
- Keywords
- Helminths, Oxfendazole, Pharmacokinetics, Safety
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 12 May 2017 (actual)
- Primary completion
- 23 Apr 2018 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 17 Dec 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant women aged 18-45 followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or following a high fat meal. The study duration will be approximately 12 months with each subject participation lasting approximately 6 weeks. In the multiple ascending dose evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and monitored for 7 days from the time of the first dose for predefined adverse events. If there are no predefined safety events, a second sentinel subject will be enrolled and followed for a total of 7 days. If there are no predefined safety signals identified for either of these two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight subjects have completed the 10 day follow up period, an electronic safety review of the electronic data will be performed. If none of the predefined safety events have occurred DMID will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined adverse events prior to enrolling the remaining subjects in the group. After the 10 day follow up period has been completed for group 2, an electronic safety review will be completed and if no predefined events have occurred two sequential subjects (one at a time with 7 days between each subject) will be enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined safety events prior to enrolling the remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled into the single dose cross over group where half of the subjects will initially receive a single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then cross over to receive a single dose following a high fat breakfast or fasting period (water is permitted). All subjects will have received a dose of oxfendazole following both a fasting period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole administered daily for five days; and 2) To assess the safety of oxfendazole administered as a single dose with or without food.
Detailed description
This Phase I study is an open label multiple ascending dose evaluation of the safety and PK of oxfendazole (3, 7.5, or 15 mg/kg) given orally daily to healthy adult men and nonpregnant women aged 18-45 followed by a single dose cross over trial evaluating the safety and pharmacokinetics of a single dose of oxfendazole (3 mg/kg) given following an 8 hour fast or following a high fat meal. The study duration will be approximately 12 months with each subject participation lasting approximately 6 weeks. In the multiple ascending dose evaluation, between 8 and 24 subjects will be enrolled; each dose group will be comprised of eight volunteers. To enhance safety, one sentinel subject will be dosed for five days and monitored for 7 days from the time of the first dose for predefined adverse events. If there are no predefined safety events, a second sentinel subject will be enrolled and followed for a total of 7 days. If there are no predefined safety signals identified for either of these two sentinel subjects, the remaining subjects in the group will be enrolled. After all eight subjects have completed the 10 day follow up period, an electronic safety review of the electronic data will be performed. If none of the predefined safety events have occurred DMID will approve enrollment into the second dose group (7.5 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined adverse events prior to enrolling the remaining subjects in the group. After the 10 day follow up period has been completed for group 2, an electronic safety review will be completed and if no predefined events have occurred two sequential subjects (one at a time with 7 days between each subject) will be enrolled into the third dose group (15 mg/kg oxfendazole daily x 5 days) and will be monitored for a total of 7 days each for predefined safety events prior to enrolling the remaining subjects in the group. In the food effects evaluation, 12 subjects will be enrolled into the single dose cross over group where half of the subjects will initially receive a single dose of 3 mg/kg of oxfendazole following an 8 hour fast and the other half will receive a single dose of 3 mg/kg of oxfendazole following a high fat meal. Subjects will then cross over to receive a single dose following a high fat breakfast or fasting period (water is permitted). All subjects will have received a dose of oxfendazole following both a fasting period and a meal. The primary objectives are: 1) To assess the safety of oxfendazole administered daily for five days; and 2) To assess the safety of oxfendazole administered as a single dose with or without food. The secondary objectives are: 1) To define the multi-dose kinetics of oxfendazole; and 2) To determine the effect of food on the kinetics of oxfendazole.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Oxfendazole3 mg/kg orally once daily for 5 days (n = 8) |
| 2 | Experimental | Drug: Oxfendazole7.5 mg/kg orally once daily for 5 days (n = 8) |
| 3 | Experimental | Drug: Oxfendazole15 mg/kg orally once daily for 5 days (n = 8) |
| 4 | Experimental | Drug: Oxfendazole3 mg/kg orally, one dose received following a fast (n=6) or high fat meal (n=6) on Day 1 and crossed over to opposite arm to receive drug following high fat meal or fast on Day 8 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Males and nonpregnant females between the ages of 18 and 45 years, inclusive.
- Women of childbearing potential* must agree to practice adequate contraception** for the 28-day period before Day 0 through 4 months after the last dose of study medication.
- Acceptable birth control methods include but are not limited to: abstinence from sexual intercourse with men; monogamous relationship with a vasectomized partner; double-barrier methods (condoms, diaphragms, spermicides); intrauterine devices; and licensed hormonal methods.
- In good health, as judged by the investigator and determined by vital signs*
- Temperature < 38°C, 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. Acceptable screening laboratories: Hemoglobin, white blood cell (WBC) count, neutrophil, and platelet counts, INR and PTT within normal ranges. AST < 44 and ALT < 44 and total bilirubin, creatinine must be equal to or below the upper limit of normal (creatinine 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.
Key exclusion criteria (18 listed)
- Pregnant women, women who are planning to become pregnant in the next 4 months, or women who are breastfeeding.
- Body temperature >=100.4°F (>=38.0°C) or acute illness within 3 days before administration of study drug (subject may be rescheduled).
- Chronic or acute medical disorder*
- Use of chronic systemic medications* *Intermittent use of over the counter medications such as acetaminophen, ibuprofen, cold and sinus medications are permitted for enrollment Topical medications, nasal steroids are permitted throughout the study. Use of prescription medications used less than once per week on average are permitted for enrollment. 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.
- 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 |
|---|---|---|
| Oxfendazolemethyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, is a broad spectrum benzimidazole antihelminthic. It is the sulphoxide metabolite of fenbendazole. | Drug | 1, 2, 3, 4 |
Primary outcome
Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arms 1, 2, and 3
Time frame: Day 1 through Day 10
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."
Number of Subjects Reporting Adverse Events (AEs) Related to Oxfendazole for Arm 4
Time frame: Day 1 through Day 14
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 for a Single Dosing Interval (AUCtau) of Oxfendazole for Arm 1, 2 and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Area Under the Concentration Time-curve to the Time of Last Measured Concentration (AUClast) of Oxfendazole for Arm 4
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arms 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma for Arm 4
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arms 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Terminal Elimination Half-life (t1/2) of Oxfendazole for Arm 4
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arms 1, 2, and 3
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose on day 1 and 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24, 72, 120 hours post-dose on day 5
Time of Maximum Observed Concentration (Tmax) of Oxfendazole for Arm 4
Time frame: 0, 0.5, 1, 2, 3, 4, 6, 9, 12, 24 hours post-dose
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32816721Bach T, Galbiati S, Kennedy JK, Deye G, Nomicos EYH, Codd EE, Garcia HH, Horton J, Gilman RH, Gonzalez AE, Winokur P, An G. Pharmacokinetics, Safety, and Tolerability of Oxfendazole in Healthy Adults in an Open-Label Phase 1 Multiple Ascending Dose and Food Effect Study. Antimicrob Agents Chemother. 2020 Oct 20;64(11):e01018-20. doi: 10.1128/AAC.01018-20. Print 2020 Oct 20.
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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 Helminthic Infection, 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 11 inclusion and 18 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 17 Dec 2019. 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 17 Dec 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 (AEs) Related to Oxfendazole for Arms 1, 2, and 3 (time frame: Day 1 through Day 10). The study lists 2 primary outcomes in all. 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 NCT03035760, 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 17 Dec 2019.