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

NCT ID: NCT06918665

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE1

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-05-31

Study Completion Date

2027-08-01

Brief Summary

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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

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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.

Conditions

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Scabies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomised, Open-Label Cross-over
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation)

Ivermectin standard 3mg tablet

washout 21 days

ivermectin infant formula preparation

Group Type ACTIVE_COMPARATOR

ivermectin infant formula preparation

Intervention Type DRUG

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 ivermectin 3mg tablet

Intervention Type DRUG

standard 3mg ivermectin tablet

Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet)

ivermectin infant formula preparation

21 days washout

ivermectin standard 3mg tablet

Group Type ACTIVE_COMPARATOR

ivermectin infant formula preparation

Intervention Type DRUG

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 ivermectin 3mg tablet

Intervention Type DRUG

standard 3mg ivermectin tablet

Interventions

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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.

Intervention Type DRUG

Standard ivermectin 3mg tablet

standard 3mg ivermectin tablet

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Monash University

OTHER

Sponsor Role collaborator

Murdoch Childrens Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amanda Gwee

Role: PRINCIPAL_INVESTIGATOR

Murdoch Childrens Research Institute

Locations

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The Royal Children's Hospital

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

References

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Hauschke D, Steinijans VW, Pigeot I. Bioequivalence Studies in Drug Development. Chichester: John Wiley; 2007

Reference Type BACKGROUND

European Medicines Agency. (2010). Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr). Available at https://www.tga.gov.au.

Reference Type BACKGROUND

Yotsu RR, Fuller LC, Murdoch ME, van Brakel WH, Revankar C, Barogui MYT, Postigo JAR, Dagne DA, Asiedu K, Hay RJ. A global call for action to tackle skin-related neglected tropical diseases (skin NTDs) through integration: An ambitious step change. PLoS Negl Trop Dis. 2023 Jun 15;17(6):e0011357. doi: 10.1371/journal.pntd.0011357. eCollection 2023 Jun.

Reference Type BACKGROUND
PMID: 37319139 (View on PubMed)

Engelman D, Marks M, Steer AC, Beshah A, Biswas G, Chosidow O, Coffeng LE, Lardizabal Dofitas B, Enbiale W, Fallah M, Gasimov E, Hopkins A, Jacobson J, Kaldor JM, Ly F, Mackenzie CD, McVernon J, Parnaby M, Rainima-Qaniuci M, Sokana O, Sankara D, Yotsu R, Yajima A, Cantey PT. A framework for scabies control. PLoS Negl Trop Dis. 2021 Sep 2;15(9):e0009661. doi: 10.1371/journal.pntd.0009661. eCollection 2021 Sep.

Reference Type BACKGROUND
PMID: 34473725 (View on PubMed)

Ponsonby-Thomas E, Pham AC, Huang S, Salim M, Klein LD, Offersen SM, Thymann T, Boyd BJ. Human milk improves the oral bioavailability of the poorly water-soluble drug clofazimine. Eur J Pharm Biopharm. 2025 Feb;207:114604. doi: 10.1016/j.ejpb.2024.114604. Epub 2024 Dec 13.

Reference Type BACKGROUND
PMID: 39675684 (View on PubMed)

Naranjo CA, Busto U, Sellers EM, Sandor P, Ruiz I, Roberts EA, Janecek E, Domecq C, Greenblatt DJ. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther. 1981 Aug;30(2):239-45. doi: 10.1038/clpt.1981.154. No abstract available.

Reference Type BACKGROUND
PMID: 7249508 (View on PubMed)

Gwee A, Steer A, Phongluxa K, Luangphaxay C, Senggnam K, Philavanh A, Lei A, Martinez A, Huang S, McWhinney B, Ungerer J, Duffull S, Yang W, Zhu X, Coghlan B. Ivermectin therapy for young children with scabies infection: a multicentre phase 2 non-randomized trial. Lancet Reg Health West Pac. 2024 Jul 13;49:101144. doi: 10.1016/j.lanwpc.2024.101144. eCollection 2024 Aug.

Reference Type BACKGROUND
PMID: 39109221 (View on PubMed)

Karimkhani C, Colombara DV, Drucker AM, Norton SA, Hay R, Engelman D, Steer A, Whitfeld M, Naghavi M, Dellavalle RP. The global burden of scabies: a cross-sectional analysis from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2017 Dec;17(12):1247-1254. doi: 10.1016/S1473-3099(17)30483-8. Epub 2017 Sep 21.

Reference Type BACKGROUND
PMID: 28941561 (View on PubMed)

Dabira ED, Soumare HM, Conteh B, Ceesay F, Ndiath MO, Bradley J, Mohammed N, Kandeh B, Smit MR, Slater H, Peeters Grietens K, Broekhuizen H, Bousema T, Drakeley C, Lindsay SW, Achan J, D'Alessandro U. Mass drug administration of ivermectin and dihydroartemisinin-piperaquine against malaria in settings with high coverage of standard control interventions: a cluster-randomised controlled trial in The Gambia. Lancet Infect Dis. 2022 Apr;22(4):519-528. doi: 10.1016/S1473-3099(21)00557-0. Epub 2021 Dec 15.

Reference Type BACKGROUND
PMID: 34919831 (View on PubMed)

Other Identifiers

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118266

Identifier Type: -

Identifier Source: org_study_id