Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606860
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
Safety Tolerability and PK of Single and Multiple Doses of Oxantel Pamoate Tablets
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Placebo Controlled Double-Blind 3-Arm Phase I Study to Investigate the Safety Tolerability and Pharmacokinetics of Single and Multiple Doses of 20 mgkg Oxantel Pamoate in Healthy Adult Volunteers
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
HELP-OXA
Brief 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
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 mgkg 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 mgkg 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
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 mgkg 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 mgkg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None