HealthyPhase 1HELP-OXANCT06606860
Safety, Tolerability and PK of Single and Multiple Doses of Oxantel Pamoate Tablets
A Phase 1 study testing Oxantel Pamoate in people with Healthy, run by Swiss Tropical & Public Health Institute at 1 site in Tanzania.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oxantel Pamoate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteTanzania
- Study dates
- 27 Jan 2025to 8 Apr 2025
- 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 or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants, aged between 18 to 45 years at the time of consent.
- Written informed consent (IC) obtained before any study procedure.
- 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 (following a test with a maximum of two attempts). 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 from at least 28 days prior to first dosage to 30 days after discharge from the ward.
- Normal body weight range (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. tea, coffee, cola or chocolate 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 20Show fewer
- Medical, social condition, psychiatric disorder or occupational reasons that, in the judgment of the Investigator, is a contraindication to the protocol, 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 (BP) and heart rate (HR) in supine position at the screening examination outside the ranges (systolic BP range: 105-136 mm Hg systolic, diastolic BP range: 58-84 mm Hg diastolic; HR range: 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.
- Known renal or hepatic impairment
- Participants with a history of allergies, non-allergic drug reactions, adverse reaction to any drug, or multiple drug allergies.
- 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 volunteer\'s participation in the trial or make it unnecessarily hazardous.
- Relevant pathological abnormalities in the electrocardiogram (ECG) such as a second or third-degree 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 human immunodeficiency virus (HIV), hepatitis B or C.
- Positive stool or urine test for helminth infestation by Kato-Katz, urine filtration or Baermann test.
- Positive for malaria by thick blood smear (TBS).
- Presence of abnormal physical findings, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Placebo Controlled, Double-Blind, 3-Arm Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of 20 mg/kg Oxantel Pamoate in Healthy Adult Volunteers
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.
Read the detailed description
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:
- Study arm 1, 20 participants: Treatment with single dose of 20 mg/kg oxantel pamoate on day 1 followed by administration of two daily doses placebo
- Study arm 2, 20 participants: Treatment with three daily dose of 20 mg/kg oxantel pamoate
- Study arm 3, 5 participants: Treatment with three daily dose of placebo PK sampling will be performed at 13 defined time points (baseline included).
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.
- Conditions
- Healthy
- Being tested
- Oxantel Pamoate, Placebo
- Keywords
- Soil transmitted helminths, Phase I, Safety, Tolerability, Pharmacokinetics, Trichuriasis, Whipworm, Parasitic Diseases, Neglected Diseases
- Medical subject headings
- Trichuriasis, Parasitic Diseases, Neglected Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxantel PamoateDrug
Oxantel Pamoate tablet, 250mg
PlaceboDrug
Placebo tablet
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Treatment with a single dose of 20 mg/kg oxantel pamoate followed by administration of two daily doses placebo Receives: Drug: Oxantel Pamoate |
| Arm 2 | Experimental | Treatment with three daily dose of 20 mg/kg oxantel pamoate Receives: Drug: Oxantel Pamoate |
| Arm 3 | Placebo comparator | Treatment with three daily doses of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After first dosage on day 0 to day 14
Heart rate from baseline
Change of pulse rate from baseline
Measured: 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
Measured: After first dosage on day 0 to day 14
Temperature from baseline
Change of axillary temperature from baseline
Measured: After first dosage on day 0 to day 14
Respiratory rate from baseline
Change of respiratory rate from baseline
Measured: After first dosage on day 0 to day 14
Creatinine value from baseline
Change of creatinine value from baseline
Measured: After first dosage on day 0 to day 14
Alanine aminotransferase value from baseline
Change of alanine aminotransferase value from baseline
Measured: After first dosage on day 0 to day 14
Aspartate aminotransferase value from baseline
Change of aspartate aminotransferase value from baseline
Measured: After first dosage on day 0 to day 14
Total bilirubin value from baseline
Change of total bilirubin value from baseline
Measured: After first dosage on day 0 to day 14
Sodium value from baseline
Change of sodium value from baseline
Measured: After first dosage on day 0 to day 14
Potassium value from baseline
Change of potassium value from baseline
Measured: After first dosage on day 0 to day 14
Blood urea nitrogen value from baseline
Change of blood urea nitrogen value from baseline
Measured: After first dosage on day 0 to day 14
Haemoglobin value from baseline
Change of haemoglobin value from baseline
Measured: After first dosage on day 0 to day 14
Red blood cell count from baseline
Change of red blood cell count from baseline
Measured: After first dosage on day 0 to day 14
Mean corpuscular volume from baseline
Change of mean corpuscular volume from baseline
Measured: After first dosage on day 0 to day 14
Mean corpuscular haemoglobin value from baseline
Change of mean corpuscular haemoglobin value from baseline
Measured: After first dosage on day 0 to day 14
Mean corpuscular haemoglobin concentration from baseline
Change of mean corpuscular haemoglobin concentration from baseline
Measured: After first dosage on day 0 to day 14
Platelets value from baseline
Change of platelets value from baseline
Measured: After first dosage on day 0 to day 14
White blood cell count from baseline
Change of white blood cell count from baseline
Measured: After first dosage on day 0 to day 14
Neutrophils value from baseline
Change of neutrophils value from baseline
Measured: After first dosage on day 0 to day 14
Lymphocytes value from baseline
Change of lymphocytes value from baseline
Measured: After first dosage on day 0 to day 14
Monocytes value from baseline
Change of monocytes value from baseline
Measured: After first dosage on day 0 to day 14
Eosinophils value from baseline
Change of eosinophils value from baseline
Measured: After first dosage on day 0 to day 14
Basophils value from baseline
Change of basophils value from baseline
Measured: After first dosage on day 0 to day 14
Prothrombin time from baseline
Change of prothrombin time value from baseline
Measured: After first dosage on day 0 to day 14
Activated partial thromboplastin time from baseline
Change of activated partial thromboplastin time value from baseline
Measured: After first dosage on day 0 to day 14
Protein in urine from baseline
Change of proteine in urine from baseline
Measured: After first dosage on day 0 to day 14
Blood in urine from baseline
Change of blood in urine from baseline
Measured: After first dosage on day 0 to day 14
Secondary outcomes (7)
Cmax of oxantel pamoate
Peak Plasma Concentration (Cmax) of oxantel pamoate, if detectable
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start27 Jan 2025
- Primary completion8 Apr 2025
- Study completion8 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 45 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 initiative
- Responsible party
- Sponsor
- Investigators
- Daniel Paris, MD, PhD, Study director, Swiss Tropical & Public Health InstituteJennifer Keiser, PhD, Study chair, Swiss Tropical & Public Health InstituteHussein Mbarak, MD, Principal investigator, Ifakara Health Insitute, Tanzania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06606860
- Sponsor's protocol ID
- P1773-22A
- Acronym
- HELP-OXA
- Status last verified
- Aug 2025
- First submitted
- 12 Sep 2024
- Last updated
- 28 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Placebo Controlled, Double-Blind, 3-Arm Phase I Study to Investigate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses of 20 mg/kg Oxantel Pamoate in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT06606860
- Acronym / sponsor ID
- HELP-OXA / P1773-22A
- Conditions
- Healthy
- Keywords
- Soil transmitted helminths, Phase I, Safety, Tolerability, Pharmacokinetics, Trichuriasis, Whipworm, Parasitic Diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Swiss Tropical & Public Health InstituteUniversity, hospital or other
- Collaborators
- Ifakara Health Institute, Drugs for Neglected Diseases initiative
- Study start
- 27 Jan 2025 (actual)
- Primary completion
- 8 Apr 2025 (actual)
- Study completion
- 8 Apr 2025 (actual)
- First posted
- 23 Sep 2024 (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 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.
Detailed description
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:
- Study arm 1, 20 participants: Treatment with single dose of 20 mg/kg oxantel pamoate on day 1 followed by administration of two daily doses placebo
- Study arm 2, 20 participants: Treatment with three daily dose of 20 mg/kg oxantel pamoate
- Study arm 3, 5 participants: Treatment with three daily dose of placebo PK sampling will be performed at 13 defined time points (baseline included).
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Oxantel PamoateTreatment with a single dose of 20 mg/kg oxantel pamoate followed by administration of two daily doses placebo |
| Arm 2 | Experimental | Drug: Oxantel PamoateTreatment with three daily dose of 20 mg/kg oxantel pamoate |
| Arm 3 | Placebo comparator | Drug: PlaceboTreatment with three daily doses of placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy adult male or non-pregnant (confirmed by a negative serum pregnancy test) and non-breastfeeding female participants, aged between 18 to 45 years at the time of consent.
- Written informed consent (IC) obtained before any study procedure.
- 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 (following a test with a maximum of two attempts). 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 from at least 28 days prior to first dosage to 30 days after discharge from the ward.
- Normal body weight range (BMI between 18 and 29.9 kg/ m2).
Key exclusion criteria (20 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. tea, coffee, cola or chocolate 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 |
|---|---|---|
| Oxantel PamoateOxantel Pamoate tablet, 250mg | Drug | Arm 1, Arm 2 |
| PlaceboPlacebo tablet | Drug | Arm 3 |
Primary outcome
General safety (number, frequency, severity, seriousness and duration of adverse events)
Time frame: After first dosage on day 0 to day 14
Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events, treatment emerging adverse events
Heart rate from baseline
Time frame: After first dosage on day 0 to day 14
Change of pulse rate from baseline
Blood pressure from baseline
Time frame: After first dosage on day 0 to day 14
Change of blood pressure from baseline. Systolic and diastolic blood pressure will be assessed
Temperature from baseline
Time frame: After first dosage on day 0 to day 14
Change of axillary temperature from baseline
Respiratory rate from baseline
Time frame: After first dosage on day 0 to day 14
Change of respiratory rate from baseline
Creatinine value from baseline
Time frame: After first dosage on day 0 to day 14
Change of creatinine value from baseline
Alanine aminotransferase value from baseline
Time frame: After first dosage on day 0 to day 14
Change of alanine aminotransferase value from baseline
Aspartate aminotransferase value from baseline
Time frame: After first dosage on day 0 to day 14
Change of aspartate aminotransferase value from baseline
Total bilirubin value from baseline
Time frame: After first dosage on day 0 to day 14
Change of total bilirubin value from baseline
Sodium value from baseline
Time frame: After first dosage on day 0 to day 14
Change of sodium value from baseline
Potassium value from baseline
Time frame: After first dosage on day 0 to day 14
Change of potassium value from baseline
Blood urea nitrogen value from baseline
Time frame: After first dosage on day 0 to day 14
Change of blood urea nitrogen value from baseline
Haemoglobin value from baseline
Time frame: After first dosage on day 0 to day 14
Change of haemoglobin value from baseline
Red blood cell count from baseline
Time frame: After first dosage on day 0 to day 14
Change of red blood cell count from baseline
Mean corpuscular volume from baseline
Time frame: After first dosage on day 0 to day 14
Change of mean corpuscular volume from baseline
Mean corpuscular haemoglobin value from baseline
Time frame: After first dosage on day 0 to day 14
Change of mean corpuscular haemoglobin value from baseline
Mean corpuscular haemoglobin concentration from baseline
Time frame: After first dosage on day 0 to day 14
Change of mean corpuscular haemoglobin concentration from baseline
Platelets value from baseline
Time frame: After first dosage on day 0 to day 14
Change of platelets value from baseline
White blood cell count from baseline
Time frame: After first dosage on day 0 to day 14
Change of white blood cell count from baseline
Neutrophils value from baseline
Time frame: After first dosage on day 0 to day 14
Change of neutrophils value from baseline
Lymphocytes value from baseline
Time frame: After first dosage on day 0 to day 14
Change of lymphocytes value from baseline
Monocytes value from baseline
Time frame: After first dosage on day 0 to day 14
Change of monocytes value from baseline
Eosinophils value from baseline
Time frame: After first dosage on day 0 to day 14
Change of eosinophils value from baseline
Basophils value from baseline
Time frame: After first dosage on day 0 to day 14
Change of basophils value from baseline
Prothrombin time from baseline
Time frame: After first dosage on day 0 to day 14
Change of prothrombin time value from baseline
Activated partial thromboplastin time from baseline
Time frame: After first dosage on day 0 to day 14
Change of activated partial thromboplastin time value from baseline
Protein in urine from baseline
Time frame: After first dosage on day 0 to day 14
Change of proteine in urine from baseline
Blood in urine from baseline
Time frame: After first dosage on day 0 to day 14
Change of blood in urine from baseline
7 secondary outcomes
Cmax of oxantel pamoate
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 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
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
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
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
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
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
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 28 Aug 2025.
- Individual participant dataSharing planned: No
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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, MD, PhD study director
Swiss Tropical & Public Health Institute
Jennifer Keiser, PhD study chair
Swiss Tropical & Public Health Institute
Hussein Mbarak, MD principal investigator
Ifakara Health Insitute, Tanzania
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 Oxantel Pamoate in people with Healthy, 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 5 inclusion and 20 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 28 Aug 2025. 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. Some participants in this study may receive a placebo. 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?
General safety (number, frequency, severity, seriousness and duration of adverse events) (time frame: After first dosage on day 0 to day 14). The study lists 28 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Aug 2025.