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

Swiss Tropical & Public Health Institute1 个研究点分布在 1 个国家目标入组 45 人开始时间: 2025年1月27日最近更新: 2025年8月28日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方: Swiss Tropical & Public Health Institute
入组人数: 45
试验地点: 1
主要终点: Aspartate aminotransferase value from baseline

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Parallel
主要目的: Treatment
盲法: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: All
接受健康志愿者: 是

入选标准

•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).

排除标准

•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 of trial medication.
•Use of dietary supplements or herbal remedies (such as St John's Wort) known to interfere with the CYP3A4 and/or P-gp metabolic pathway during the 28 days before the first dose of trial medication.
•Therapies which may impact on the interpretation of study results in the opinion of the Investigator.
•Medical, social condition, psychiatric disorder or occupational reasons that, in the judgment of the Investigator, is a contraindication to the protocol, may impair the volunteer's ability to give informed consent or effectively participate in the study, may significantly increase the risk to the volunteer because of participation in the study or may impair interpretation of the study data.
•Blood pressure (BP) and heart rate (HR) in supine position at the screening examination outside the ranges (systolic BP range: 105-136 mm Hg systolic, diastolic BP range: 58-84 mm Hg diastolic; HR range: 56- 96 beats/min).
•Febrile illness within 1 week before the start of study treatment.
•History of relevant diseases of vital organs, of the central nervous system or other organs.
•Known renal or hepatic impairment
•Participants with a history of allergies, non-allergic drug reactions, adverse reaction to any drug, or multiple drug allergies.
•Presence or history of drug or alcohol abuse in the last 10 years.
•Surgery (e.g. stomach bypass) or medical condition that might affect absorption of study drug taken orally.
•Clinically relevant abnormal medical history, concurrent medical condition, acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
•Relevant pathological abnormalities in the electrocardiogram (ECG) such as a second or third-degree AV block, prolongation of the QRS complex over 120 msec or of the QTcF-interval over 450 msec (corrected interval according to Fridericia's formula).
•Positive test for human immunodeficiency virus (HIV), hepatitis B or C.
•Positive stool or urine test for helminth infestation by Kato-Katz, urine filtration or Baermann test.
•Positive for malaria by thick blood smear (TBS).
•Presence of abnormal physical findings, or laboratory values at the screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.

研究组 & 干预措施

Arm 1

Experimental

Treatment with a single dose of 20 mg/kg oxantel pamoate followed by administration of two daily doses placebo

干预措施: Oxantel Pamoate (Drug)

Arm 2

Experimental

Treatment with three daily dose of 20 mg/kg oxantel pamoate

干预措施: Oxantel Pamoate (Drug)

Arm 3

Placebo Comparator

Treatment with three daily doses of placebo

干预措施: Placebo (Drug)