Clinical trial NCT06918665: HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
Official title: HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Scabies
Keywords: ivermectin
Lead sponsor: Murdoch Childrens Research Institute
Sponsor class: OTHER
Collaborators: name: Monash University
First posted: 2025-04-09
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomised, Open-Label Cross-over
Primary purpose: TREATMENT

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 determine if the new formulation functions in the same way, tastes the same and causes no new side effects. The trial will involve 52 participants who will be healthy adult volunteers. The participants will receive both formulations - the order they receive each formulation will be assigned randomly (similar to the toss of a coin).

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. Participants will be randomised to receive one of these two formulations at the start of the trial and after a 21 day wash out period will be given the alternative formulation. Blood samples will be taken to determine serum drug concentrations. The bioequivalence, tolerability and drug-related adverse effects will be evaluated.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
timeFrame: 31 days
measure: Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
timeFrame: 31 days
Secondary outcomes:
measure: Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation
timeFrame: 51 days
measure: Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)
timeFrame: 51 days
Other outcomes:
Locations:
city: Melbourne
country: Australia
facility: The Royal Children's Hospital
state: Victoria
Study officials:
affiliation: Murdoch Childrens Research Institute
name: Amanda Gwee
role: PRINCIPAL_INVESTIGATOR
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