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

NCT06918665 | Suspended Phase 1

• 1 other identifier: 118266
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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).

Conditions

Scabies

Keywords

ivermectin

Outcome Measures

Primary Outcomes (2)

• 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%.

  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%.

  31 days

Secondary Outcomes (2)

• Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation

  51 days

• Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)

  51 days

Study Arms (2)

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

ACTIVE COMPARATOR

Ivermectin standard 3mg tablet washout 21 days ivermectin infant formula preparation

Drug: ivermectin infant formula preparation; Drug: Standard ivermectin 3mg tablet

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

ACTIVE COMPARATOR

ivermectin infant formula preparation 21 days washout ivermectin standard 3mg tablet

Drug: ivermectin infant formula preparation; Drug: Standard ivermectin 3mg tablet

Interventions

ivermectin infant formula preparation 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.

Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation); Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet)

Standard ivermectin 3mg tablet DRUG

standard 3mg ivermectin tablet

Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation); Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Murdoch Childrens Research Institute: lead
• Monash University: collaborator

Study Sites (1)

The Royal Children's Hospital

Melbourne, Victoria, 3016, Australia

Location

Related Publications (9)

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

  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.

  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.

  PMID: 37319139 BACKGROUND

• 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.

  PMID: 34473725 BACKGROUND

• 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.

  PMID: 39675684 BACKGROUND

• 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.

  PMID: 7249508 BACKGROUND

• 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.

  PMID: 39109221 BACKGROUND

• 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.

  PMID: 28941561 BACKGROUND

• 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.

  PMID: 34919831 BACKGROUND

MeSH Terms

Conditions

Scabies

Interventions

Tablets

Condition Hierarchy (Ancestors)

Mite Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic; Parasitic Diseases; Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Amanda Gwee

  Murdoch Childrens Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised, Open-Label Cross-over

Study Record Dates

• First Submitted: March 31, 2025
• First Posted: April 9, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)