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PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets (HELP-OFZ)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04920292
Recruitment Status : Recruiting
First Posted : June 9, 2021
Last Update Posted : June 6, 2022
Sponsor:
Collaborators:
Ifakara Health Institute
Drugs for Neglected Diseases
Information provided by (Responsible Party):
Swiss Tropical & Public Health Institute

Brief Summary:
The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.

Condition or disease Intervention/treatment Phase
Filariasis Drug: Oxfendazole Drug: Placebo Phase 1

Detailed Description:
This is a randomized, placebo-controlled, double blinded, single center phase I bioavailability study with two Single Dose cohorts and one Multiple Doses cohort in a total of 30 healthy male and female healthy volunteers (10 per cohort).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1, Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of an Oxfendazole Tablet Formulation in a Randomized, Double-Blind, Placebo-Controlled Design After Single and Multiple Oral Dosing in Healthy Adult Volunteers
Actual Study Start Date : May 23, 2022
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Oxfendazole

Arm Intervention/treatment
Experimental: Single Dose of 100mg Oxfendazole versus Placebo
8 participants will receive a single oral dose of 100mg of oxfendazole. 2 participants will receive a single oral dose of placebo.
Drug: Oxfendazole
Oxfendazole is a benzimidazole anthelminthic drug.

Drug: Placebo
The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.

Experimental: Single Dose of 400mg Oxfendazole versus Placebo
8 participants will receive a single oral dose of 400mg of oxfendazole. 2 participants will receive a single oral dose of placebo.
Drug: Oxfendazole
Oxfendazole is a benzimidazole anthelminthic drug.

Drug: Placebo
The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.

Experimental: Multiple Doses of 400mg Oxfendazole versus Placebo

8 participants will receive multiple oral doses of 400mg of oxfendazole on 5 consecutive days.

2 participants will receive multiple oral doses of placebo on 5 consecutive days.

Drug: Oxfendazole
Oxfendazole is a benzimidazole anthelminthic drug.

Drug: Placebo
The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.




Primary Outcome Measures :
  1. Area under the plasma concentration curve from time zero to the last quantifiable concentration at time t (AUC0-t) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 48 hours after single dose administration ]
    For single dose arms

  2. Area under the plasma concentration curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 48 hours after single dose administration ]
    For single dose arms

  3. Maximum observed concentration (Cmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 48 hours after single dose administration ]
    For single dose arms

  4. Time to maximum observed concentration (Tmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 48 hours after single dose administration ]
    For single dose arms

  5. Elimination half-life (t1/2) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 48 hours after single dose administration ]
    For single dose arms

  6. Area under the plasma concentration curve over dosing interval (AUCtau) of oxfendazole and its metabolites fenbendazole [ Time Frame: At different time points from pre-dose up to 72 hours after last dose administration ]
    For multiple doses arm

  7. Accumulation Ratio (Racc) of oxfendazole and its metabolites fenbendazole [ Time Frame: At different time points from pre-dose up to 72 hours after last dose administration ]
    For multiple doses arm

  8. Maximum observed concentration (Cmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 72 hours after last dose administration ]
    For multiple doses arm

  9. Time to maximum observed concentration (Tmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 72 hours after last dose administration ]
    For multiple doses arm

  10. Elimination half-life (t1/2) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone [ Time Frame: At different time points from pre-dose up to 72 hours after last dose administration ]
    For multiple doses arm


Secondary Outcome Measures :
  1. Safety and tolerability of oxfendazole as measured by number of participants with treatment related adverse events and serious adverse events [ Time Frame: From Day 1 to Day 14. ]
    Number of participants with treatment related adverse events and serious adverse events

  2. Safety and tolerability of oxfendazole as measured by number of participants with physical examination findings [ Time Frame: At different time points from baseline to Day 14 ]
    Number of participants with physical examination findings. Standard examination done on skin, lymph nodes, head, eyes, ears, nose, throat, respiratory, cardiovascular, abdomen, extremities, musculoskeletal, and neurological.

  3. Safety and tolerability of oxfendazole as measured by number of participants with vital signs findings [ Time Frame: At different time points from baseline to Day 14 ]
    Number of participants with vital signs findings (heart rate, blood pressure, axillar temperature, respiratory rate,)

  4. Safety and tolerability of oxfendazole as measured by number of participants with clinical laboratory test findings [ Time Frame: At different time points from baseline to Day 14 ]
    Number of participants with relevant abnormal clinical laboratory tests results (hematology (hemoglobin, white blood cells (differentiation of eosinophils and neutrophils) and platelets), coagulation (prothrombin time and activated partial thromboplastin time), biochemistry (Creatinine, Alanine aminotransferase, Aspartate aminotransferase, total bilirubin, sodium, potassium, chloride, bicarbonate, blood urea nitrogen), urinalysis (proteinuria and glucose))

  5. Safety and tolerability of oxfendazole as measured by number of participants with 12-lead ECG findings Safety and tolerability of oxfendazole as measured by the change in ECG parameters [ Time Frame: Pre-dose, 1 and 2 hours after single dose administration on Day 1; Pre-dose, 1 and 2 hours after dose administration on Day 1 and pre-dose, 1 and 2 hours after dose administration on Day 5 (last dose) for multiple doses administration arm. ]
    Number of participants with 12-lead ECG findings (heart rate (HR), PR interval, QRS, QT, QTcB, QTcF, cardiac rhythm and T wave morphology)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult male and non-pregnant (confirmed by pregnancy test) and non-breastfeeding female participants (18 to 45 years of age at the time of consent).
  • Willingness to give written consent to participate in the trial, after reading the participant information and consent form and after having had the opportunity to discuss the trial with the Investigator or any delegate.
  • Ability to read and write and to understand the participant information sheet and the nature of the trial and any hazards from participating in it. Ability to communicate satisfactorily with the Investigator and to participate in, and comply with the requirements of, the entire trial.
  • Women of childbearing potential (WOCBP) must agree to use a highly effective form of contraception in combination with a barrier method from at least 28 days prior to first dosage to 30 days after last dosage.
  • Male participants must be willing to ensure the use of condoms from the first dosage to 90 days after last dosage.
  • Normal body weight range (body mass index (BMI) between 18 and 29.9 kg/ m2)

Exclusion Criteria:

  • Participation in another clinical trial within 3 months prior to the study, or within 5-times the half-life of the drug tested in the previous clinical trial, whichever is longer. (Time calculated relative to the last dose in the previous clinical trial).
  • Regular daily consumption of more than one liter of xanthine-containing beverages (e.g. chocolates, tea, coffee or cola drinks).
  • Regular daily consumption of more than 5 cigarettes daily.
  • Use of a prescription medicine during the 28 days before the first dose of trial medication or use of an over-the-counter medicine, during the 7 days before the first dose of trial medication.
  • Use of dietary supplements or herbal remedies (such as St John's Wort) known to interfere with the CYP3A4 and/or P-gp metabolic pathway during the 28 days before the first dose of trial medication.
  • Therapies which may impact on the interpretation of study results in the opinion of the Investigator.
  • Medical, social condition, psychiatric disorder or occupational reasons that, in the judgment of the Investigator, is a contraindication to protocol participation, may impair the volunteer's ability to give informed consent or effectively participate in the study, may significantly increase the risk to the volunteer because of participation in the study or may impair interpretation of the study data.
  • Blood pressure and heart rate in supine position at the screening examination outside one (or more) of the ranges 105-136 mm Hg systolic, 58-84 mm Hg diastolic; heart rate 56- 96 beats/min.
  • Febrile illness within 1 week before the start of study treatment.
  • History of relevant diseases of vital organs, of the central nervous system or other organs.
  • Participants with a history of allergies, non-allergic drug reactions, adverse reaction to any drug, or multiple drug allergies.
  • Participants with a hypersensitivity to the investigational drug, related benzimidazole compounds or the control agent and/ or to inactive constituents.
  • Presence or history of drug or alcohol abuse in the last 10 years.
  • Surgery (e.g. stomach bypass) or medical condition that might affect absorption of study drug taken orally.
  • Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness or history of chronic illness sufficient to invalidate the subject's participation in the trial or make it unnecessarily hazardous.
  • Relevant pathological abnormalities in the ECG such as a second or third-degree atrioventricular (AV) block, prolongation of the QRS complex over 120 msec or of the QTcF-interval over 450 msec (corrected interval according to Fridericia's formula).
  • Positive test for hepatitis B or C.
  • Positive test for HIV.
  • Positive pregnancy test (WOCBP).
  • Positive stool or urine test for helminth infestation by Kato-Katz, urine filtration or Baermann test.
  • Positive for malaria by thick blood smear.
  • Positive test for (neuro-) cysticercosis.
  • Positive test for echinococcosis.
  • Positive test for onchocerciasis.
  • Presence of abnormal physical findings, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the subject.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04920292


Contacts
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Contact: Eveline Ackermann +41612848111 eveline.ackermann@swisstph.ch
Contact: Elisabeth Reus elisabeth.reus@swisstph.ch

Locations
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Tanzania
Ifakara Health Institute Recruiting
Bagamoyo, Tanzania
Contact: Said Jongo       sjongo@ihi.or.tz   
Principal Investigator: Said Jongo         
Sponsors and Collaborators
Swiss Tropical & Public Health Institute
Ifakara Health Institute
Drugs for Neglected Diseases
Investigators
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Study Director: Daniel Paris Swiss TPH
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Responsible Party: Swiss Tropical & Public Health Institute
ClinicalTrials.gov Identifier: NCT04920292    
Other Study ID Numbers: P1773-20A
First Posted: June 9, 2021    Key Record Dates
Last Update Posted: June 6, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: It is intended that Summary results will be shared once Clinical Study Report will be available.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Swiss Tropical & Public Health Institute:
Onchocerciasis
Parasitic Diseases
Neglected Disease
Phase I
Safety
Tolerability
Pharmacokinetics
Bioavailability
Volunteers
Additional relevant MeSH terms:
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Filariasis
Spirurida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases
Infections
Oxfendazole
Anthelmintics
Antiparasitic Agents
Anti-Infective Agents
Antinematodal Agents