Status:
SUSPENDED
HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
Lead Sponsor:
Murdoch Childrens Research Institute
Collaborating Sponsors:
Monash University
Conditions:
Scabies
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
Brief Summary
This is a clinical trial to compare two formulations of the drug ivermectin: the standard 3mg tablet formulation versus a newly developed infant formula preparation. The goal of the trial is to determ...
Detailed Description
Randomised open-label cross-over trial of 52 healthy adult volunteers comparing two ivermectin formulations: the standard tablet formulation, and a newly developed infant formula preparation. Particip...
Eligibility Criteria
Inclusion
- Adult aged over 18 years up to 55 years; and
- Body mass index of 18.0 - 32.0 kg/m2 with body weight ≥ 50.0 kg; and
- Medically healthy, determined by medical history, physical examination, no clinically significant abnormalities on baseline blood tests, vital signs (blood pressure, oxygen saturation and heart rate) as deemed by the study Doctor; and
- Females must be non-pregnant, non-lactating or postmenopausal for at least 1 year or surgically sterile for at least 6 months prior to dosing; and
- Sexually active, non-pregnant female participants will be required to use an effective form of contraception from 28 days prior to study until end of study; and
- Males must not have a pregnant partner and must agree to use condoms as a method of contraception from the time of signing informed consent until end of the study; and
- Must be willing and able to read, understand, and sign the participant information and consent form. Willing to comply with all study requirements, including the inpatient period and outpatient visits for the duration of the study; and
- Good venous access on at least one arm as assessed by study staff.
Exclusion
- History of any clinically important cardiac, endocrinologic, haematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, and renal, or other major disease, as determined by the study doctor; or
- Known allergy to ivermectin or taking a drug that interacts with ivermectin via the P-glycoprotein transport system (e.g. amiodarone, carvedilol, clarithromycin, clotrimazole); or
- Currently taking warfarin; or
- Known lactose intolerance or cow's protein intolerance; or
- Known elective surgery scheduled within the next 3 months; or
- Inability to comply with the study protocol.
Key Trial Info
Start Date :
May 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT06918665
Start Date
May 1 2026
End Date
August 1 2027
Last Update
December 16 2025
Active Locations (1)
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1
The Royal Children's Hospital
Melbourne, Victoria, Australia, 3016