HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation

Launched by MURDOCH CHILDRENS RESEARCH INSTITUTE · Apr 1, 2025

Keywords

ClinConnect Summary

The HEALTH Trial is a clinical study that aims to compare two types of ivermectin, a medication often used to treat scabies. The researchers want to see if a new formulation designed for infants works just as well as the standard 3mg tablet that adults typically take. They will also check if the new version tastes the same and whether it causes any new side effects. The trial will involve 52 healthy adult volunteers who will try both formulations, but the order in which they receive them will be randomly assigned, similar to flipping a coin.

To participate, individuals must be between 18 and 55 years old, in good health, and meet certain weight and health criteria. Women who take part must not be pregnant or breastfeeding. Participants can expect to stay in the study for a while, following specific guidelines, and they will need to undergo health checks throughout the trial. This study is currently not recruiting participants, but it is an important step in ensuring that the new infant formulation is safe and effective.

Gender

ALL

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.