NCT04920292

PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets

A Phase 1, Bioavailability Study to Investigate the Pharmacokinetics, Safety and Tolerability of an Oxfendazole Tablet Formulation in a Randomized, Double-Blind, Placebo-Controlled Design After Single and Multiple Oral Dosing in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Swiss Tropical & Public Health Institute · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The study evaluates the pharmacokinetics (PK), safety and tolerability of oxfendazole, after administration as a tablet formulation in healthy male and female participants.

Detailed description

This is a randomized, placebo-controlled, double blinded, single center phase I bioavailability study with two Single Dose cohorts and one Multiple Doses cohort in a total of 30 healthy male and female healthy volunteers (10 per cohort).

Conditions

• Filariasis

Interventions

Type	Name	Description
DRUG	Oxfendazole	Oxfendazole is a benzimidazole anthelminthic drug.
DRUG	Placebo	The placebo tablet is made using the same non-active ingredients and matches the investigational tablet.

Timeline

• Start date: 2022-04-21
• Primary completion: 2022-11-07
• Completion: 2022-11-14
• First posted: 2021-06-09
• Last updated: 2022-12-20

Locations

1 site across 1 country: Tanzania