Scabies
Conditions
Keywords
ivermectin
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).
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.
Interventions
DRUGivermectin 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.
DRUGStandard ivermectin 3mg tablet
standard 3mg ivermectin tablet
Sponsors
Murdoch Childrens Research Institute
Monash University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomised, Open-Label Cross-over
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum ivermectin Area Under the Curve (AUC) 0-96h bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation) | 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%. |
| Serum ivermectin Maximum Concentration (Cmax) bioequivalence across the 2 formulations (standard ivermectin tablet versus new infant formula preparation) | 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%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety as measured by the proportion of participants experiencing one or more drug-related adverse effect(s) with each ivermectin formulation | 51 days | Proportion of participants who experience one or more drug-related adverse effects with each ivermectin formulation |
| Palatability of the new infant formula preparation as measured by a visual analogue scale (VAS) | 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. |
Countries
Australia
Contacts
PRINCIPAL_INVESTIGATORAmanda Gwee
Murdoch Childrens Research Institute
Outcome results
None listed