Ignite Creation Date:
2025-12-24 @ 3:50 PM
Ignite Modification Date:
2026-01-14 @ 6:28 PM
Study NCT ID:
NCT04920292
Status:
COMPLETED
Last Update Posted:
2022-12-20
First Post:
2021-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PK, Safety and Tolerability of Single and Multiple Doses of Oxfendazole Tablets
Sponsor:
Swiss Tropical & Public Health Institute
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2022-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELP-OFZ
Brief 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).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: