A Phase 1 interventional study of Oxantel Pamoate and Placebo in Healthy, sponsored by Swiss Tropical & Public Health Institute. Completed at 1 site in Tanzania. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-28.
Sponsored by Swiss Tropical & Public Health Institute · Phase 1, Interventional, and Treatment
The goal of this clinical trial is to evaluate the safety, tolerability and pharmacokinetics of oxantel pamoate tablet after administration of a single and multiple dose in healthy male and female adult volunteers.
The main questions aim to answer if oxantel pamoate is safe and well tolerated in healthy volunteers and if is it absorbed by the human body.
A single dose and a multiple dose of oxantel pamoate will be compared to placebo to see if there are any different effects.
Objectives:
Primary objective:
To investigate the safety and tolerability of oxantel pamoate after single and multiple oral administration of a chewable tablet formulation.
Secondary objective:
To investigate the pharmacokinetics (PK) of oxantel pamoate after single and multiple oral administration of a chewable tablet formulation.
Study Design:
This is a randomized, placebo controlled, double blind, 3-arm Phase I single centre study in a total of 45 healthy adults. The participants will be randomized into one of the following three study arms:
The participants will be admitted to the ward one day prior to commencement of the study treatment (day -1) and will stay until one day after the last dose has been administered. They will have a final follow-up visit on day 14. The safety and tolerability will be assessed as of the first dosage up to the last follow-up visit. Biochemistry, haematology, coagulation and urinalysis will be checked at baseline, day 3 and at the final follow-up visit.
30 studies on the registry are indexed under Trichuriasis; 7 are open to participants now.
This study's enrollment of 45 is below the median of 315 across 27 interventional studies indexed under Trichuriasis.
Browse Trichuriasis studies →Swiss Tropical & Public Health Institute is the lead sponsor of 58 studies on the registry; 9 are open to participants now.
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.
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.
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.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
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.
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.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
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.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
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.
Treatment with a single dose of 20 mg/kg oxantel pamoate followed by administration of two daily doses placebo
Drug: Oxantel Pamoate
Treatment with three daily dose of 20 mg/kg oxantel pamoate
Drug: Oxantel Pamoate
Treatment with three daily doses of placebo
Drug: Placebo
Oxantel Pamoate tablet, 250mg
Placebo tablet
General safety (number, frequency, severity, seriousness and duration of adverse events)
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events, treatment emerging adverse events
Time frame: After first dosage on day 0 to day 14
Heart rate from baseline
Change of pulse rate from baseline
Time frame: After first dosage on day 0 to day 14
Blood pressure from baseline
Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed
Time frame: After first dosage on day 0 to day 14
Temperature from baseline
Change of axillary temperature from baseline
Time frame: After first dosage on day 0 to day 14
Respiratory rate from baseline
Change of respiratory rate from baseline
Time frame: After first dosage on day 0 to day 14
Creatinine value from baseline
Change of creatinine value from baseline
Time frame: After first dosage on day 0 to day 14
Alanine aminotransferase value from baseline
Change of alanine aminotransferase value from baseline
Time frame: After first dosage on day 0 to day 14
Aspartate aminotransferase value from baseline
Change of aspartate aminotransferase value from baseline
Time frame: After first dosage on day 0 to day 14
Total bilirubin value from baseline
Change of total bilirubin value from baseline
Time frame: After first dosage on day 0 to day 14
Sodium value from baseline
Change of sodium value from baseline
Time frame: After first dosage on day 0 to day 14
Potassium value from baseline
Change of potassium value from baseline
Time frame: After first dosage on day 0 to day 14
Blood urea nitrogen value from baseline
Change of blood urea nitrogen value from baseline
Time frame: After first dosage on day 0 to day 14
Haemoglobin value from baseline
Change of haemoglobin value from baseline
Time frame: After first dosage on day 0 to day 14
Red blood cell count from baseline
Change of red blood cell count from baseline
Time frame: After first dosage on day 0 to day 14
Mean corpuscular volume from baseline
Change of mean corpuscular volume from baseline
Time frame: After first dosage on day 0 to day 14
Mean corpuscular haemoglobin value from baseline
Change of mean corpuscular haemoglobin value from baseline
Time frame: After first dosage on day 0 to day 14
Mean corpuscular haemoglobin concentration from baseline
Change of mean corpuscular haemoglobin concentration from baseline
Time frame: After first dosage on day 0 to day 14
Platelets value from baseline
Change of platelets value from baseline
Time frame: After first dosage on day 0 to day 14
White blood cell count from baseline
Change of white blood cell count from baseline
Time frame: After first dosage on day 0 to day 14
Neutrophils value from baseline
Change of neutrophils value from baseline
Time frame: After first dosage on day 0 to day 14
Lymphocytes value from baseline
Change of lymphocytes value from baseline
Time frame: After first dosage on day 0 to day 14
Monocytes value from baseline
Change of monocytes value from baseline
Time frame: After first dosage on day 0 to day 14
Eosinophils value from baseline
Change of eosinophils value from baseline
Time frame: After first dosage on day 0 to day 14
Basophils value from baseline
Change of basophils value from baseline
Time frame: After first dosage on day 0 to day 14
Prothrombin time from baseline
Change of prothrombin time value from baseline
Time frame: After first dosage on day 0 to day 14
Activated partial thromboplastin time from baseline
Change of activated partial thromboplastin time value from baseline
Time frame: After first dosage on day 0 to day 14
Protein in urine from baseline
Change of proteine in urine from baseline
Time frame: After first dosage on day 0 to day 14
Blood in urine from baseline
Change of blood in urine from baseline
Time frame: After first dosage on day 0 to day 14
Cmax of oxantel pamoate
Peak Plasma Concentration (Cmax) of oxantel pamoate, if detectable
Time frame: Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
Tmax of oxantel pamoate
Time to reach Cmax (Tmax), in case of plasma concentration determined.
Time frame: Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
AUC of oxantel pamoate
Area under the curve (AUC) of the plasma concentration determined.
Time frame: Plasma samples taken pre-dose -0.5 hours, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
AUC (0-t) of oxantel pamoate
Concentration from time zero to the last quantifiable concentration at time t, in case plasma concentration can be determined.
Time frame: Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
T1/2 of oxantel pamoate
The plasma elimination half-life, In case plasma concentration can be determined.
Time frame: Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
AUC (tau) of oxantel pamoate
The area under the plasma concentration curve over dosing interval, in case plasma concentration can be determined.
Time frame: Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
AUC (0-∞) of oxantel pamoate
The AUC of the plasma concentration from time zero to infinity with extrapolation of the terminal phase, In case plasma concentration can be determined.
Time frame: Plasma samples taken pre-dose -0.5 hours prior first dose, then 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after first dose and 1 hour, 3 hours, 5 hours, 8 hours, 12 hours, 24 hours after third dose
Plan to share: No
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Ran from Jan 2025 to primary completion in Apr 2025, 2 months.
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This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Swiss Tropical & Public Health Institute