A Phase 1 interventional study of Oxfendazole and Placebo in Neurocysticercosis, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Completed at 1 site in United States. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-02.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Phase 1, Interventional, and Treatment
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.
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.
21 studies on the registry are indexed under Neurocysticercosis; 5 are open to participants now.
This study's enrollment of 70 is below the median of 107 across 13 interventional studies indexed under Neurocysticercosis.
Browse Neurocysticercosis studies →National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
N=8 subjects receive single oral dose 0.5mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
N=8 subjects receive single oral dose 1mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
N=8 subjects receive single oral dose 3mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
N=8 subjects receive single oral dose 7.5mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
N=8 subjects receive single oral dose 15mg/kg of oxfendazole; N= 2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
N=8 subjects receive single oral dose 30mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
N=8 subjects receive single oral dose 60mg/kg of oxfendazole; N=2 subjects receive single oral dose placebo
Drug: Oxfendazole · Other: Placebo
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.
Normal Saline administered with an oral dosing syringe. Group 1- Group 6
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."
Time frame: Within 14 Days of first dose
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1-Day 15
Participants were healthy adult males and non-pregnant females recruited from existing volunteer populations and from the communities at large around the clinical site. Participants were enrolled between 17NOV2014 and 09NOV2015.
| Milestone | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo |
|---|---|---|---|---|---|---|---|---|
| Started | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 14 |
| Completed | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 14 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
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."
| Participants | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo |
|---|---|---|---|---|---|---|---|---|
| Number of Subjects Reporting Adverse Events Related to Oxfendazole Within 14 Days of Receipt of a Single Oral Dose. | 0 | 0 | 1 | 0 | 0 | 1 | 1 | 1 |
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
| ng•hr/mL | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| Area Under the Concentration Time-curve From Time Zero to Infinity (AUC(0-infinity)) for Oxfendazole | 11682.4 ± 44.8 | 13117.7 ± 54.4 | 30803.1 ± 20.1 | 73928.9 ± 40.6 | 99542.6 ± 23.9 | 78344.0 ± 34.4 | 108618.2 ± 38.4 |
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.
| ng/mL | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| Maximum Observed Concentration (Cmax) of Oxfendazole in Plasma | 943.9 ± 28.4 | 1155.9 ± 26.8 | 2436.9 ± 24.0 | 4781.3 ± 25.6 | 6254.8 ± 21.7 | 5301.3 ± 30.5 | 6768.4 ± 31.3 |
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.
| ng/mL | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| 1 Hour | 0 ± 0 | 0 ± 0 | 0.3 ± 0.8 | 0.3 ± 0.7 | 1.0 ± 1.4 | 1.4 ± 1.2 | 5.9 ± 2.4 |
| 2 Hours | 0 ± 0 | 0 ± 0 | 0.4 ± 0.8 | 1.1 ± 1.5 | 2.6 ± 2.5 | 2.2 ± 1.5 | 6.3 ± 2.5 |
| 4 Hours | 0.6 ± 1.8 | 0.8 ± 1.1 | 3.5 ± 2.5 | 3.0 ± 3.2 | 8.1 ± 8.0 | 4.4 ± 4.3 | 8.0 ± 3.6 |
| 6 Hours | 0.5 ± 1.3 | 2.0 ± 1.4 | 4.8 ± 2.9 | 6.6 ± 4.8 | 9.9 ± 8.3 | 5.8 ± 6.7 | 12.4 ± 4.9 |
| 8 Hours | 0.3 ± 0.9 | 1.9 ± 1.2 | 5.2 ± 2.9 | 6.7 ± 4.6 | 10.8 ± 8.3 | 5.0 ± 5.1 | 15.5 ± 8.6 |
| 10 Hours | 0.3 ± 0.8 | 2.3 ± 1.2 | 6.8 ± 2.6 | 10.0 ± 5.7 | 11.2 ± 6.6 | 5.5 ± 4.5 | 18.4 ± 11.1 |
| 12 Hours | 0.3 ± 0.9 | 2.3 ± 1.4 | 6.7 ± 2.4 | 10.1 ± 5.5 | 11.7 ± 7.9 | 6.4 ± 4.5 | 20.9 ± 19.0 |
| 24 Hours | 0.7 ± 1.0 | 2.3 ± 1.6 | 7.1 ± 2.5 | 4.9 ± 4.0 | 10.0 ± 3.7 | 5.4 ± 3.2 | 16.7 ± 12.9 |
| Day 3 | 0.4 ± 0.5 | 0.9 ± 0.4 | 3.2 ± 2.8 | 2.2 ± 1.7 | 3.7 ± 3.4 | 2.5 ± 3.1 | 5.5 ± 4.2 |
| Day 4 | 0.4 ± 0.5 | 0.9 ± 0.4 | 1.1 ± 0.4 | 1.4 ± 1.0 | 1.2 ± 0.6 | 1.3 ± 1.4 | 2.5 ± 3.0 |
| Day 6 | 0.4 ± 0.5 | 0.9 ± 0.4 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 0.9 ± 0.4 | 1.7 ± 1.9 |
| Day 8 | 0.4 ± 0.5 | 0.9 ± 0.4 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 0.9 ± 0.4 | 1.0 ± 0.0 |
| Day 15 | 0.4 ± 0.5 | 0.9 ± 0.4 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 0.9 ± 0.4 | 1.0 ± 0.0 |
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.
| ng/mL | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| 1 Hour | 28.5 ± 4.6 | 31.1 ± 11.1 | 73.0 ± 24.1 | 100.5 ± 25.4 | 111.6 ± 51.9 | 161.5 ± 41.3 | 209.1 ± 84.5 |
| 2 Hours | 48.7 ± 9.3 | 56.0 ± 11.3 | 106.3 ± 31.5 | 182.3 ± 51.6 | 219.2 ± 73.0 | 262.6 ± 72.5 | 319.0 ± 119.9 |
| 4 Hours | 52.3 ± 8.6 | 67.6 ± 16.0 | 108.1 ± 25.7 | 223.8 ± 62.5 | 258.6 ± 73.0 | 285.7 ± 74.5 | 345.4 ± 133.0 |
| 6 Hours | 57.3 ± 15.1 | 75.1 ± 26.6 | 113.8 ± 26.2 | 264.1 ± 63.0 | 308.3 ± 98.8 | 330.3 ± 90.1 | 404.6 ± 154.7 |
| 8 Hours | 59.7 ± 13.7 | 78.2 ± 27.0 | 135.5 ± 33.9 | 296.2 ± 71.5 | 336.8 ± 72.2 | 356.3 ± 120.1 | 454.8 ± 174.0 |
| 10 Hours | 62.8 ± 22.3 | 70.7 ± 28.5 | 119.4 ± 18.7 | 308.7 ± 120.1 | 340.8 ± 68.1 | 352.4 ± 106.0 | 470.7 ± 182.5 |
| 12 Hours | 56.8 ± 17.5 | 65.4 ± 30.9 | 111.4 ± 12.4 | 296.0 ± 90.3 | 359.3 ± 102.1 | 343.7 ± 111.7 | 487.7 ± 210.3 |
| 24 Hours | 30.9 ± 23.4 | 38.9 ± 31.7 | 68.5 ± 21.0 | 176.7 ± 125.5 | 261.8 ± 83.4 | 185.2 ± 90.5 | 362.2 ± 222.7 |
| Day 3 | 11.4 ± 11.8 | 11.1 ± 10.3 | 20.8 ± 12.2 | 64.8 ± 94.9 | 75.1 ± 47.6 | 57.5 ± 54.4 | 119.5 ± 86.8 |
| Day 4 | 3.6 ± 3.1 | 2.8 ± 3.5 | 5.7 ± 3.8 | 17.3 ± 27.2 | 16.7 ± 15.1 | 17.2 ± 23.6 | 33.8 ± 28.6 |
| Day 6 | 1.2 ± 0.4 | 1.3 ± 1.0 | 1.3 ± 0.8 | 6.4 ± 10.2 | 1.2 ± 0.6 | 4.0 ± 7.7 | 6.6 ± 9.4 |
| Day 8 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.1 ± 0.4 |
| Day 15 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 | 1.0 ± 0.0 |
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.
| hours | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| Terminal Elimination Half-life (t1/2) of Oxfendazole | 9.1 ± 27.5 | 8.5 ± 25.3 | 10.3 ± 35.7 | 9.6 ± 34.2 | 10.0 ± 21.8 | 9.8 ± 33.7 | 11.0 ± 44.5 |
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.
| hours | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| Time of Maximum Observed Concentration (Tmax) of Oxfendazole | 2.0 (2.0 to 2.1) | 2.0 (1.0 to 6.0) | 2.0 (1.0 to 2.0) | 2.0 (1.0 to 4.0) | 2.0 (2.0 to 9.5) | 2.0 (1.9 to 6.0) | 2.0 (1.4 to 7.9) |
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.
| ng/mL | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| 0-4 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| 4-8 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| 8-12 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| 12-24 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
| 24-32 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0.03 ± 0.07 |
| 48-60 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0.28 ± 0.78 | 0 ± 0 | 0 ± 0 | 0 ± 0 |
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.
| ng/mL | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole |
|---|---|---|---|---|---|---|---|
| 0-4 hours | 9.1 ± 16.8 | 4.1 ± 11.6 | 19.9 ± 25.7 | 45.6 ± 37.0 | 46.4 ± 20.9 | 68.0 ± 21.2 | 64.5 ± 44.5 |
| 4-8 hours | 18.9 ± 13.8 | 24.9 ± 18.3 | 38.2 ± 20.3 | 86.0 ± 68.9 | 88.1 ± 27.6 | 105.8 ± 36.4 | 124.1 ± 72.8 |
| 8-12 hours | 34.1 ± 50.3 | 26.5 ± 22.9 | 30.3 ± 14.7 | 76.0 ± 60.1 | 92.3 ± 33.3 | 99.7 ± 40.8 | 92.9 ± 39.7 |
| 12-24 hours | 18.9 ± 29.1 | 26.3 ± 33.7 | 15.8 ± 18.5 | 100.4 ± 87.2 | 91.8 ± 46.7 | 69.9 ± 49.0 | 139.0 ± 137.7 |
| 24-32 hours | 0 ± 0 | 0.9 ± 2.6 | 1.2 ± 3.4 | 3.2 ± 4.9 | 7.5 ± 9.1 | 18.2 ± 32.4 | 26.1 ± 32.4 |
| 48-60 hours | 0 ± 0 | 0 ± 0 | 0 ± 0 | 0.8 ± 1.6 | 0 ± 0 | 7.3 ± 9.7 | 5.3 ± 7.3 |
Collected over Adverse events were collected from the time of receipt of study drug on Day 1 through approximately 14 days after receipt of study product.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 0.5 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 1 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| 3 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| 7.5 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 0/8 (0%) |
| 15 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 30 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 1/8 (12.5%) |
| 60 mg/kg Oxfendazole | 0/8 (0%) | 0/8 (0%) | 2/8 (25%) |
| Placebo | 0/14 (0%) | 0/14 (0%) | 1/14 (7.1%) |
| Event | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo |
|---|---|---|---|---|---|---|---|---|
| Skin AbrasionInjury, poisoning and procedural complications | 0/8 | 2/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/14 |
| DiarrhoeaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 1/14 |
| FlatulenceGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/14 |
| NauseaGastrointestinal disorders | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 0/14 |
| Gastroenteritis ViralInfections and infestations | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/14 |
| Upper Respiratory Tract InfectionInfections and infestations | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/14 |
| Electrocardiogram PR ProlongationInvestigations | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/14 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/8 | 0/8 | 0/14 |
| HeadacheNervous system disorders | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/8 | 0/14 |
| Nasal CongestionRespiratory, thoracic and mediastinal disorders | 0/8 | 1/8 | 0/8 | 0/8 | 0/8 | 0/8 | 1/8 | 0/14 |
All participants are included in the analysis population.
| Age, Categorical(Participants) | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 14 | 70 |
| >=65 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Age, Continuous(years) | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 26.8 ± 6.7 | 26.6 ± 6.8 | 23.8 ± 6.1 | 26.3 ± 7.1 | 26.8 ± 9.3 | 22.6 ± 6.7 | 24.6 ± 8.0 | 26.9 ± 7.2 | 25.6 ± 7.1 |
| Sex: Female, Male(Participants) | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 0 | 1 | 0 | 1 | 0 | 0 | 0 | 1 | 3 |
| Male | 8 | 7 | 8 | 7 | 8 | 8 | 8 | 13 | 67 |
| Ethnicity (NIH/OMB)(Participants) | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 2 | 0 | 2 | 1 | 2 | 0 | 8 |
| Not Hispanic or Latino | 8 | 7 | 5 | 8 | 6 | 7 | 6 | 14 | 61 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 0 | 0 | 0 | 0 | 1 |
| Race (NIH/OMB)(Participants) | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 2 | 0 | 0 | 1 | 0 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 | 0 | 3 | 1 | 0 | 0 | 4 |
| White | 7 | 8 | 7 | 6 | 5 | 6 | 6 | 12 | 57 |
| More than one race | 1 | 0 | 0 | 0 | 0 | 0 | 0 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 | 1 | 1 | 0 | 2 |
| Region of Enrollment(participants) | 0.5 mg/kg Oxfendazole | 1 mg/kg Oxfendazole | 3 mg/kg Oxfendazole | 7.5 mg/kg Oxfendazole | 15 mg/kg Oxfendazole | 30 mg/kg Oxfendazole | 60 mg/kg Oxfendazole | Placebo | Total |
|---|---|---|---|---|---|---|---|---|---|
| United States | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 14 | 70 |
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Studies of the drug tested here: Oxfendazole
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