NCT06606860

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Swiss Tropical & Public Health Institute · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Oxantel Pamoate	Oxantel Pamoate tablet, 250mg
DRUG	Placebo	Placebo tablet

Timeline

• Start date: 2025-01-27
• Primary completion: 2025-04-08
• Completion: 2025-04-08
• First posted: 2024-09-23
• Last updated: 2025-08-28

Locations

1 site across 1 country: Tanzania