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 range18 Years – 45 Years

SexALL

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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…

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

Aspartate 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 range18 Years – 45 Years

SexALL

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

Aspartate aminotransferase value from baseline

Timeframe: After first dosage on day 0 to day 14