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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06918665




Registration number
NCT06918665
Ethics application status
Date submitted
31/03/2025
Date registered
9/04/2025
Date last updated
18/05/2025

Titles & IDs
Public title
HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
Scientific title
HEALTH Trial - Healthy Adult Evaluation of Ivermectin Bioequivalence: Infant Versus Standard Formulation
Secondary ID [1] 0 0
113992
Universal Trial Number (UTN)
Trial acronym
HEALTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Scabies 0 0
Condition category
Condition code
Skin 0 0 0 0
Other skin conditions
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ivermectin infant formula preparation
Treatment: Drugs - Standard ivermectin 3mg tablet

Active comparator: Sequence 1 (standard 3mg ivermectin tablet then ivermectin infant formula preparation) - Ivermectin standard 3mg tablet

washout 21 days

ivermectin infant formula preparation

Active comparator: Sequence 2 (ivermectin infant formula preparation then standard ivermectin 3mg tablet) - ivermectin infant formula preparation

21 days washout

ivermectin standard 3mg tablet


Treatment: Drugs: 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.

Treatment: Drugs: Standard ivermectin 3mg tablet
standard 3mg ivermectin tablet
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
Timepoint [1] 0 0
31 days
Primary outcome [2] 0 0
Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation)
Timepoint [2] 0 0
31 days
Secondary outcome [1] 0 0
Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation
Timepoint [1] 0 0
51 days
Secondary outcome [2] 0 0
Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS)
Timepoint [2] 0 0
51 days

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/08/2026
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
The Royal Children's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
3016 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
Murdoch Childrens Research Institute
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Monash University
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Amanda Gwee
Address 0 0
Murdoch Childrens Research Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Sharelle L Joseland
Address 0 0
Country 0 0
Phone 0 0
+61 0410052823
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06918665