FilariasisPhase 1HELP-OFZNCT04920292
PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets
A Phase 1 study testing Oxfendazole in people with Filariasis, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Filariasis
- What is being tested?
- Oxfendazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteTanzania
- Study dates
- 21 Apr 2022to 14 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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.
Show all 25Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.
Read the 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).
- Conditions
- Filariasis
- Being tested
- Oxfendazole, Placebo
- Keywords
- Onchocerciasis, Parasitic Diseases, Neglected Disease, Phase I, Safety, Tolerability, Pharmacokinetics, Bioavailability, Volunteers
- Medical subject headings
- Filariasis, Onchocerciasis, Parasitic Diseases, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxfendazoleDrug
Oxfendazole is a benzimidazole anthelminthic drug.
PlaceboDrug
The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.
| Study group | Role | What they receive |
|---|---|---|
| Single Dose of 100mg Oxfendazole versus Placebo | Experimental | 8 participants will receive a single oral dose of 100mg of oxfendazole. 2 participants will receive a single oral dose of placebo. Receives: Drug: Oxfendazole; Drug: Placebo |
| Single Dose of 400mg Oxfendazole versus Placebo | Experimental | 8 participants will receive a single oral dose of 400mg of oxfendazole. 2 participants will receive a single oral dose of placebo. Receives: Drug: Oxfendazole; Drug: Placebo |
| Multiple Doses of 400mg Oxfendazole versus Placebo | Experimental | 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. Receives: Drug: Oxfendazole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
For single dose arms
Measured: At different time points from pre-dose up to 48 hours after single dose administration
Area under the plasma concentration curve (AUC) from time zero extrapolated to infinity (AUC0-∞) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Measured: At different time points from pre-dose up to 48 hours after single dose administration
Maximum observed concentration (Cmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Measured: At different time points from pre-dose up to 48 hours after single dose administration
Time to maximum observed concentration (Tmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Measured: At different time points from pre-dose up to 48 hours after single dose administration
Elimination half-life (t1/2) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For single dose arms
Measured: At different time points from pre-dose up to 48 hours after single dose administration
Area under the plasma concentration curve over dosing interval (AUCtau) of oxfendazole and its metabolites fenbendazole
For multiple doses arm
Measured: At different time points from pre-dose up to 72 hours after last dose administration
Accumulation Ratio (Racc) of oxfendazole and its metabolites fenbendazole
For multiple doses arm
Measured: At different time points from pre-dose up to 72 hours after last dose administration
Maximum observed concentration (Cmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For multiple doses arm
Measured: At different time points from pre-dose up to 72 hours after last dose administration
Time to maximum observed concentration (Tmax) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For multiple doses arm
Measured: At different time points from pre-dose up to 72 hours after last dose administration
Elimination half-life (t1/2) of oxfendazole and its metabolites fenbendazole and fenbendazole sulfone
For multiple doses arm
Measured: At different time points from pre-dose up to 72 hours after last dose administration
Secondary outcomes (5)
Safety and tolerability of oxfendazole as measured by number of participants with treatment related adverse events and serious adverse events
Number of participants with treatment related adverse events and serious adverse events
Measured: From Day 1 to Day 14.
Safety and tolerability of oxfendazole as measured by number of participants with physical examination findings
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.
Measured: At different time points from baseline to Day 14
Safety and tolerability of oxfendazole as measured by number of participants with vital signs findings
Number of participants with vital signs findings (heart rate, blood pressure, axillar temperature, respiratory rate,)
Measured: At different time points from baseline to Day 14
Safety and tolerability of oxfendazole as measured by number of participants with clinical laboratory test findings
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))
Measured: At different time points from baseline to Day 14
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
Number of participants with 12-lead ECG findings (heart rate (HR), PR interval, QRS, QT, QTcB, QTcF, cardiac rhythm and T wave morphology)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2021
- Study start21 Apr 2022
- Primary completion7 Nov 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FilariasisStudies of the same condition, open and under way.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Tropical & Public Health Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ifakara Health Institute, Drugs for Neglected Diseases
- Responsible party
- Sponsor
- Investigators
- Daniel Paris, Study director, Swiss TPHSaid Jongo, Principal investigator, Ifakara Health Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04920292
- Sponsor's protocol ID
- P1773-20A
- Acronym
- HELP-OFZ
- Status last verified
- Dec 2022
- First submitted
- 28 May 2021
- Last updated
- 20 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is intended that Summary results will be shared once Clinical Study Report will be available.
Publications
Jongo S, Ackermann E, Nyaulingo G, Mbaraka H, Reus E, Cicconi S, Saxena M, Kassim K, Tumbo A, Rashid MA, Robinson S, Louis M, Satam V, Rocha FBDS, Scandale I, Assmus F, Keiser J, Specht S. Pharmacokinetics, safety, and tolerability of an oxfendazole tablet formulation: a phase 1, randomized, placebo-controlled trial in healthy African volunteers. Antimicrob Agents Chemother. 2026 Apr;70(4):e0131525. doi: 10.1128/aac.01315-25. Epub 2026 Feb 18.
PubMed 41705834Assmus F, Adehin A, Hoglund RM, Nyaulingo G, Mbarak H, Jongo S, Ackermann E, Reus E, Keiser J, Rocha FBDS, Specht S, Scandale I, Tarning J. Repurposing Oxfendazole for Onchocerciasis: Population Pharmacokinetics of a Tablet Formulation in Healthy African Adults. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70189. doi: 10.1002/psp4.70189.
PubMed 41662151
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04920292
- Acronym / sponsor ID
- HELP-OFZ / P1773-20A
- Conditions
- Filariasis
- Keywords
- Onchocerciasis, Parasitic Diseases, Neglected Disease, Phase I, Safety, Tolerability, Pharmacokinetics, Bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Ifakara Health Institute, Drugs for Neglected Diseases
- Study start
- 21 Apr 2022 (actual)
- Primary completion
- 7 Nov 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 9 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Dose of 100mg Oxfendazole versus Placebo | Experimental | Drug: Oxfendazole, Drug: Placebo8 participants will receive a single oral dose of 100mg of oxfendazole. 2 participants will receive a single oral dose of placebo. |
| Single Dose of 400mg Oxfendazole versus Placebo | Experimental | Drug: Oxfendazole, Drug: Placebo8 participants will receive a single oral dose of 400mg of oxfendazole. 2 participants will receive a single oral dose of placebo. |
| Multiple Doses of 400mg Oxfendazole versus Placebo | Experimental | Drug: Oxfendazole, Drug: Placebo8 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (25 listed)
- 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.
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 |
|---|---|---|
| OxfendazoleOxfendazole is a benzimidazole anthelminthic drug. | Drug | Multiple Doses of 400mg Oxfendazole versus Placebo, Single Dose of 100mg Oxfendazole versus Placebo, Single Dose of 400mg Oxfendazole versus Placebo |
| PlaceboThe placebo tablet is made using the same non-active ingredients and matches the investigational tablet. | Drug | Multiple Doses of 400mg Oxfendazole versus Placebo, Single Dose of 100mg Oxfendazole versus Placebo, Single Dose of 400mg Oxfendazole versus Placebo |
Primary outcome
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
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
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
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
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
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
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
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
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
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
5 secondary outcomes
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.
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
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 41705834Jongo S, Ackermann E, Nyaulingo G, Mbaraka H, Reus E, Cicconi S, Saxena M, Kassim K, Tumbo A, Rashid MA, Robinson S, Louis M, Satam V, Rocha FBDS, Scandale I, Assmus F, Keiser J, Specht S. Pharmacokinetics, safety, and tolerability of an oxfendazole tablet formulation: a phase 1, randomized, placebo-controlled trial in healthy African volunteers. Antimicrob Agents Chemother. 2026 Apr;70(4):e0131525. doi: 10.1128/aac.01315-25. Epub 2026 Feb 18.
- Derived from this study: PubMed 41662151Assmus F, Adehin A, Hoglund RM, Nyaulingo G, Mbarak H, Jongo S, Ackermann E, Reus E, Keiser J, Rocha FBDS, Specht S, Scandale I, Tarning J. Repurposing Oxfendazole for Onchocerciasis: Population Pharmacokinetics of a Tablet Formulation in Healthy African Adults. CPT Pharmacometrics Syst Pharmacol. 2026 Feb;15(2):e70189. doi: 10.1002/psp4.70189.
- Individual participant dataSharing planned: Undecided. It is intended that Summary results will be shared once Clinical Study Report will be available.
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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.
Daniel Paris study director
Swiss TPH
Said Jongo principal investigator
Ifakara Health Institute
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 Filariasis, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
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 6 inclusion and 25 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 20 Dec 2022. 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 Tanzania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). The study lists 10 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 NCT04920292, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.