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

March 19, 2026 updated by: Murdoch Childrens Research Institute
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).

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3016
        • The Royal Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation)

Ivermectin standard 3mg tablet

washout 21 days

ivermectin infant formula preparation
Drug: ivermectin infant formula preparation
The ivermectin infant formula preparation is produced by micronizing the standard 3mg ivermectin tablet and then blending it with Stage 1 infant formula (Blackmores brand) to produce a homogenous powder. This powder blend of ivermectin and infant formula is then filled into food grade clear capsules.
Drug: Standard ivermectin 3mg tablet
standard 3mg ivermectin tablet
Active Comparator: Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet)

ivermectin infant formula preparation

21 days washout

ivermectin standard 3mg tablet
Drug: ivermectin infant formula preparation
The ivermectin infant formula preparation is produced by micronizing the standard 3mg ivermectin tablet and then blending it with Stage 1 infant formula (Blackmores brand) to produce a homogenous powder. This powder blend of ivermectin and infant formula is then filled into food grade clear capsules.
Drug: Standard ivermectin 3mg tablet
standard 3mg ivermectin tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
Time Frame: 31 days
The serum ivermectin Area Under the Curve (AUC) 0-96h for both the new infant formula preparation and the standard 3 mg tablet will be measured. Bioequivalence is defined as the 90% Confidence Interval (CI) of the geometric mean ratio of AUC 0-96h of the infant formula preparation relative to the standard 3mg tablet falling within 80-125%.
31 days
Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
Time Frame: 31 days
The serum ivermectin Maximum Concentration (Cmax) for both the new infant formula preparation and the standard 3 mg tablet will be measured. Bioequivalence is defined as the 90% Confidence Interval (CI) of the geometric mean ratio of Cmax of the infant formula preparation relative to the standard 3mg tablet falling within 80-125%.
31 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation
Time Frame: 51 days
Proportion of participants who experience one or more drug-related adverse effects with each ivermectin formulation
51 days
Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)
Time Frame: 51 days
Palatability of the new infant formula preparation will be assessed using a visual analogue scale to assess bitterness and overall likeability. The scale used for this VAS tool will be 0 to 10. For the question on overall likeability, a higher score will correspond with a higher level of likeability. For the question on bitterness, a higher score will indicate a higher level of bitterness.
51 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Murdoch Childrens Research Institute

Collaborators

Monash University

Investigators

  • Principal Investigator: Amanda Gwee, Murdoch Childrens Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

August 1, 2027

Study Registration Dates

First Submitted

March 31, 2025

First Submitted That Met QC Criteria

April 1, 2025

First Posted (Actual)

April 9, 2025

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 118266

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Beginning 12 months following analysis and article publication, upon approval of the request, the following will be made available long-term for the use by future researchers from a recognised research institute whose proposed use of the data has been ethically reviewed and approved by an independent committee and who accepts MCRI's condition for access:

  • Individual participant data that underlie the results reported in this article after de-identification (text, tables, figures and appendices)
  • Trial Protocol, PICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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