A Phase 1 interventional study of ivermectin infant formula preparation and Standard ivermectin 3mg tablet in Scabies, sponsored by Murdoch Childrens Research Institute. Suspended at 1 site in Australia. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Murdoch Childrens Research Institute · Phase 1, Interventional, and Treatment
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).
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.
51 studies on the registry are indexed under Scabies; 10 are open to participants now.
This study's planned enrollment of 52 is below the median of 183 across 41 interventional studies indexed under Scabies.
Browse Scabies studies →Murdoch Childrens Research Institute is the lead sponsor of 99 studies on the registry; 34 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ivermectin standard 3mg tablet washout 21 days ivermectin infant formula preparation
Drug: ivermectin infant formula preparation · Drug: Standard ivermectin 3mg tablet
ivermectin infant formula preparation 21 days washout ivermectin standard 3mg tablet
Drug: ivermectin infant formula preparation · Drug: Standard ivermectin 3mg tablet
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.
standard 3mg ivermectin tablet
Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
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%.
Time frame: 31 days
Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
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%.
Time frame: 31 days
Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation
Proportion of participants who experience one or more drug-related adverse effects with each ivermectin formulation
Time frame: 51 days
Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)
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.
Time frame: 51 days
Plan to share: Yes — 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
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is suspended, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Murdoch Childrens Research Institute