CClinicalTrials.gg
Sign In
CompletedNCT06606860HELP-OXAUpdated Aug 28, 2025

Safety, Tolerability and PK of Single and Multiple Doses of Oxantel Pamoate Tablets

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

Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Healthy

Keywords

  • Soil transmitted helminths
  • Phase I
  • Safety
  • Tolerability
  • Pharmacokinetics
  • Trichuriasis
  • Whipworm
  • Parasitic Diseases
  • Neglected Diseases
03

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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).

Exclusion criteria

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. 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.
  • 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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Arm 1

    Treatment with a single dose of 20 mg/kg oxantel pamoate followed by administration of two daily doses placebo

    Drug: Oxantel Pamoate

  • Experimental
    Arm 2

    Treatment with three daily dose of 20 mg/kg oxantel pamoate

    Drug: Oxantel Pamoate

  • Placebo comparator
    Arm 3

    Treatment with three daily doses of placebo

    Drug: Placebo

Interventions

  • DrugOxantel Pamoate

    Oxantel Pamoate tablet, 250mg

  • DrugPlacebo

    Placebo tablet

05

What researchers measure

Primary outcomes

  1. 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

  2. Heart rate from baseline

    Change of pulse rate from baseline

    Time frame: After first dosage on day 0 to day 14

  3. 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

  4. Temperature from baseline

    Change of axillary temperature from baseline

    Time frame: After first dosage on day 0 to day 14

  5. Respiratory rate from baseline

    Change of respiratory rate from baseline

    Time frame: After first dosage on day 0 to day 14

  6. Creatinine value from baseline

    Change of creatinine value from baseline

    Time frame: After first dosage on day 0 to day 14

  7. Alanine aminotransferase value from baseline

    Change of alanine aminotransferase value from baseline

    Time frame: After first dosage on day 0 to day 14

  8. Aspartate aminotransferase value from baseline

    Change of aspartate aminotransferase value from baseline

    Time frame: After first dosage on day 0 to day 14

  9. Total bilirubin value from baseline

    Change of total bilirubin value from baseline

    Time frame: After first dosage on day 0 to day 14

  10. Sodium value from baseline

    Change of sodium value from baseline

    Time frame: After first dosage on day 0 to day 14

  11. Potassium value from baseline

    Change of potassium value from baseline

    Time frame: After first dosage on day 0 to day 14

  12. 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

  13. Haemoglobin value from baseline

    Change of haemoglobin value from baseline

    Time frame: After first dosage on day 0 to day 14

  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

  15. Mean corpuscular volume from baseline

    Change of mean corpuscular volume from baseline

    Time frame: After first dosage on day 0 to day 14

  16. 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

  17. 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

  18. Platelets value from baseline

    Change of platelets value from baseline

    Time frame: After first dosage on day 0 to day 14

  19. 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

  20. Neutrophils value from baseline

    Change of neutrophils value from baseline

    Time frame: After first dosage on day 0 to day 14

  21. Lymphocytes value from baseline

    Change of lymphocytes value from baseline

    Time frame: After first dosage on day 0 to day 14

  22. Monocytes value from baseline

    Change of monocytes value from baseline

    Time frame: After first dosage on day 0 to day 14

  23. Eosinophils value from baseline

    Change of eosinophils value from baseline

    Time frame: After first dosage on day 0 to day 14

  24. Basophils value from baseline

    Change of basophils value from baseline

    Time frame: After first dosage on day 0 to day 14

  25. Prothrombin time from baseline

    Change of prothrombin time value from baseline

    Time frame: After first dosage on day 0 to day 14

  26. 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

  27. Protein in urine from baseline

    Change of proteine in urine from baseline

    Time frame: After first dosage on day 0 to day 14

  28. Blood in urine from baseline

    Change of blood in urine from baseline

    Time frame: After first dosage on day 0 to day 14

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

06

Study locations

1 site
  • Ifakara Health Institute
    Bagamoyo, Tanzania
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06606860
Lead sponsor
Swiss Tropical & Public Health Institute
Collaborators
Ifakara Health Institute, Drugs for Neglected Diseases initiative
Responsible party
Sponsor
First posted
Sep 23, 2024
Start date
Jan 27, 2025
Primary completion
Apr 8, 2025
Completion
Apr 8, 2025
Last update
Aug 28, 2025

Study contacts

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

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Trichuriasis→

Other studies from this sponsor

Swiss Tropical & Public Health Institute

Start the discussion