CompletedPhase 1

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

Tanzania45 participantsStarted 2025-01-27

Plain-language 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.

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: * 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 o…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

General safety (number, frequency, severity, seriousness and duration of adverse events)

Timeframe: After first dosage on day 0 to day 14

Heart rate from baseline

Timeframe: After first dosage on day 0 to day 14

Blood pressure from baseline

Timeframe: After first dosage on day 0 to day 14

Temperature from baseline

Timeframe: After first dosage on day 0 to day 14

Respiratory rate from baseline

Timeframe: After first dosage on day 0 to day 14

Creatinine value from baseline

Timeframe: After first dosage on day 0 to day 14

Alanine aminotransferase value from baseline

Timeframe: After first dosage on day 0 to day 14

Trial details

NCT IDNCT06606860

SponsorSwiss Tropical & Public Health Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-04-08

View on ClinicalTrials.gov More Healthy trials

Plain-language summary

Who can participate

Age range

18 Years – 45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

General safety (number, frequency, severity, seriousness and duration of adverse events)

Timeframe: After first dosage on day 0 to day 14

Heart rate from baseline

Timeframe: After first dosage on day 0 to day 14

Blood pressure from baseline

Timeframe: After first dosage on day 0 to day 14

Temperature from baseline

Timeframe: After first dosage on day 0 to day 14

Respiratory rate from baseline

Timeframe: After first dosage on day 0 to day 14

Creatinine value from baseline

Timeframe: After first dosage on day 0 to day 14

Alanine aminotransferase value from baseline

Timeframe: After first dosage on day 0 to day 14