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The effective dose of moxidectin to treat human scabies is not known. This study aims to provide proof of concept that a single dose of moxidectin is effective in eliminating the scabies parasite in humans and to enable the determination of an optimal dose of moxidectin for treatment of scabies for further clinical studies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxidectin 2 mg | Experimental | Moxidectin 2 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. |
|
| Moxidectin 8 mg | Experimental | Moxidectin 8 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. |
|
| Moxidectin 20 mg | Experimental | Moxidectin 20 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. |
|
| Moxidectin 36 mg | Experimental | Moxidectin 36 mg will be administered as a single dose. Each subject will receive the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Moxidectin Oral Product | Drug | The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mortality Rate for Adult Scabies Mites | Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites. | 28 days |
| Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject. | Day 0 to Day 28 inclusive |
| Number of Participants and Severity of Adverse Events | Number of participants with Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of IP. Data up to and including the Day 28 assessment for each subject. The severity of adverse events were assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials. | Day 0 to Day 28 inclusive |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Moxidectin Plasma Concentrations | The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL). | Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Scabies Signs and Symptoms | The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment. | 28 days |
| Severity of Pruritus |
Inclusion Criteria:
Exclusion Criteria:
History of chronic or recurring dermatologic disease (other than scabies) that could interfere with the diagnosis and/or subsequent clinical assessment of scabies.
Diagnosis of crusted/Norwegian scabies or scabies that, in the opinion of the Investigator, would require treatment with more than one standard of care (e.g. scabies requiring concurrent topical and oral treatment).
Received any treatment for scabies within 7 days of Screening, including but not limited to permethrin, ivermectin, benzyl benzoate, lindane, crotamiton, malathion, and/or tea tree oil.
Presence of any other clinically relevant condition, including infection, immunological disorder, malignant disease, and/or other underlying condition or circumstance at Screening or Baseline that would put the subject at increased risk from participating in the study or confound study evaluations.
Poor venous access.
Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer).
Body Mass Index over 35 kg/m2.
Clinically relevant abnormal findings in vital signs, 12-lead electrocardiogram (ECG), or physical examination at Screening and/or Baseline in the opinion of the Investigator.
Clinically relevant laboratory abnormalities at Screening, including:
Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin.
Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids, or use of topical steroids for 7 out of the 14 days prior to Screening.
Subjects with known or suspected Loa loa coinfection.
Difficulty swallowing tablets.
Pregnant or breastfeeding, or planning to become pregnant.
Known or suspected alcohol or illicit substance abuse.
Unwilling, unlikely or unable to comply with all protocol specified assessments.
Previous enrolment and treatment with moxidectin in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Darwin Hospital | Darwin | Australia | ||||
| Medizinischen Universität Wien |
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The study was open to recruitment on 13 Jan 2020 and the First participant was screened on 15 Jan 2020. Last participant last study visit was completed on 28 Feb 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | Moxidectin 2 mg | 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets |
| FG001 | Moxidectin 8 mg | 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets |
| FG002 | Moxidectin 20 mg | 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets |
| FG003 | Moxidectin 36 mg | 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Analysis Population is all enrolled subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | Moxidectin 2 mg | 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets |
| BG001 | Moxidectin 8 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Mortality Rate for Adult Scabies Mites | Adult scabies mite death was based on the reflectance confocal microscopy (RCM) morphology assessment of 2 live adult scabies mites nominated pre-treatment (Baseline), hence overall number of units analyzed are different from the overall number of participants. For the outcome measure, the number of adult mites assessed at each timepoint is the sum of the number of adult mites from all participants in the analysis population for each dose. Therefore, mortality was assessed in 2 mites in the 2 mg group, 6 in the 8 mg group, 8 in the 20 mg group and 14 in the 32 mg group. Adult mite death was defined as the degradation (homogenization of internal structures and/or external anatomic structures, and increased reflectance) of the adult mite observed by RCM. The number of dead mites was assessed at Hours 4, 8, 24, 48 and 72, and Days 7, 14 and 28 compared to the baseline adult mites. | Per protocol analysis set | Posted | Number | Adult mites | 28 days | Total number of live adult mites | Total number of live adult mites |
|
Day 0 to Week 12, inclusive.
Treatment-emergent adverse events (TEAEs) were defined as adverse events that started or worsened on or after the start of investigational product administration. TEAEs that occurred in more than 5% of subjects overall are reported. The most commonly occurring TEAEs are defined as those occurring in two or more subjects (5%) overall.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Moxidectin 2 mg | 4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MeDRA 24.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MeDRA 24.1 | Non-systematic Assessment |
Small number of subjects, especially in the per-protocol analysis set, confounds interpretation of some study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Medicines Development for Global Health Limited | +61 399122400 | MDGH-MOX-2001@medicinesdevelopment.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_ICF | Yes | No | Yes | Study Protocol and Informed Consent Form | Jun 19, 2020 | May 7, 2023 | Prot_ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 16, 2022 | May 7, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D012532 | Scabies |
| ID | Term |
|---|---|
| D008924 | Mite Infestations |
| D004478 | Ectoparasitic Infestations |
| D012876 | Skin Diseases, Parasitic |
| D010272 | Parasitic Diseases |
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Parallel, double blind, multicenter, randomized, pharmacokinetic/pharmacodynamic study. Three cohorts of six subjects per cohort are planned. Subjects will be randomized 1:1:1 to receive 2, 8 or 20 mg moxidectin as a single oral dose. An additional cohort of 36 mg may be initiated with a target sample size of 6 subjects.
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To maintain blinding to treatment allocation, all subjects will receive treatment with the same number of tablets, comprised of moxidectin 2 mg tablets and matched placebo (as required).
| Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL). | Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h) |
The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable"
| 28 days |
| Vienna |
| Austria |
| Hopital Henri Mondor AP-HP | Créteil | France |
| CHU Nice Hopital Archet 2 | Nice | France |
| CHU Saint-Etienne Hopital Nord | Saint-Priest-en-Jarez | France |
4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets |
| BG002 | Moxidectin 20 mg | 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets |
| BG003 | Moxidectin 36 mg | 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Mass Index | One subject did not have height or weight measured at Baseline, therefore a BMI could not be derived for this subject hence n=3 for this parameter. | Mean | Standard Deviation | kg/m^2 |
|
| OG000 |
| Moxidectin 2 mg |
4 Participants received Moxidectin 2 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 2 mg oral tablets |
| OG001 | Moxidectin 8 mg | 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets |
| OG002 | Moxidectin 20 mg | 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets |
| OG003 | Moxidectin 36 mg | 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets |
|
|
| Primary | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | No formal statistical analysis of AEs was undertaken. Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of Investigational Product (Moxidectin). Moxidectin was generally well tolerated, with no treatment-related SAEs reported and no treatment emergent adverse event (TEAEs) leading to study withdrawal or resulting in death. Treatment-Emergent Adverse Events by MedDRA System Organ Class and Preferred Term. Data up to and including the Day 28 assessment for each subject. | The Safety Analysis Set (SfAS) included all subjects exposed to study drug. Subjects were analyzed according to the actual dose of study drug received regardless of their randomized dose group. Unless otherwise noted, the SfAS was used for all safety analyses. Reported data table represent the number of participants with most commonly occurring Adverse Events by Preferred Term. | Posted | Count of Participants | Participants | Day 0 to Day 28 inclusive |
|
|
|
| Primary | Number of Participants and Severity of Adverse Events | Number of participants with Adverse events reported in this Section refer to treatment emergent adverse events (TEAE), defined as AEs that started, or worsened, on or after the start of the administration of IP. Data up to and including the Day 28 assessment for each subject. The severity of adverse events were assessed using the Toxicity Grading Scale for Healthy Adult and Adolescent volunteers Enrolled in Preventive Vaccine Clinical Trials. | The Safety Analysis Set (SAS) included all subjects exposed to study drug. Subjects were analyzed according to the actual dose of study drug received regardless of their randomized dose group. Unless otherwise noted, the SfAS was used for all safety analyses. | Posted | Count of Participants | Participants | Day 0 to Day 28 inclusive |
|
|
|
| Secondary | Analysis of Moxidectin Plasma Concentrations | The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL). | Pharmacokinetic parameters were calculated and derived using non-compartmental methods. AUC calculation method was linear up log down. | Posted | Geometric Mean | Geometric Coefficient of Variation | hr*ng/mL | Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h) |
|
|
|
| Secondary | Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | The final PK analysis dataset included a total of 240 evaluable PK samples from 22 subjects. All pre-dose samples were below the limit of quantitation (BQL). | Cmax was calculated and derived using non-compartmental methods. | Posted | Geometric Mean | Geometric Coefficient of Variation | Cmax (ng/mL) | Nominal time of PK sample collection was Pre-dose, 2hours (h), 3h, 4h, 8h, Day 1 (24h), Day 2 (48h), Day 3 (72h), Day 7 (168h), Day 14 (336h) and Day 28 (672h) |
|
|
|
| Other Pre-specified | Incidence and Severity of Scabies Signs and Symptoms | The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment. | Not Posted | 28 days | Participants |
| Other Pre-specified | Severity of Pruritus | The severity of pruritus will be determined using the Numerical Rating Scale where 0="no itch" and 10="worst itch imaginable" | Not Posted | 28 days | Participants |
| 0 |
| 4 |
| 0 |
| 4 |
| 4 |
| 4 |
| EG001 | Moxidectin 8 mg | 4 Participants received Moxidectin 8 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 8 mg oral tablets | 0 | 4 | 0 | 4 | 4 | 4 |
| EG002 | Moxidectin 20 mg | 6 Participants received Moxidectin 20 mg as a single dose. Each participant received the same number of tablets made up of moxidectin 2 mg tablets and placebo tablets to maintain the blind. Moxidectin Oral Product: 20 mg oral tablets | 0 | 6 | 0 | 6 | 6 | 6 |
| EG003 | Moxidectin 36 mg | 8 Participants received Moxidectin 36 mg as a single dose. Moxidectin Oral Product: 36 mg oral tablets | 0 | 8 | 1 | 8 | 8 | 8 |
| Uterine haemorrhage | Reproductive system and breast disorders | MeDRA 24.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MeDRA 24.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MeDRA 24.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MeDRA 24.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MeDRA 24.1 | Systematic Assessment |
|
| Rash papular | Skin and subcutaneous tissue disorders | MeDRA 24.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MeDRA 24.1 | Systematic Assessment |
|
| Acarodermatitis | Infections and infestations | MeDRA 24.1 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MeDRA 24.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MeDRA 24.1 | Systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MeDRA 24.1 | Systematic Assessment |
|
| Dermatitis | Skin and subcutaneous tissue disorders | MeDRA 24.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MeDRA 24.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MeDRA 24.1 | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MeDRA 24.1 | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MeDRA 24.1 | Systematic Assessment |
|
Institution agrees that no Publication of the Study results may be made until Publication of the results of the Study or 2 years after Study Completion, whichever is the sooner.
The Institution must ensure that the Discloser gives a copy of any proposed Publication drafted by them and/or other Personnel involved in the conduct of the Study to the Sponsor at least 40 days before forwarding it to any person that is not bound by the confidentiality obligations
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Skin and subcutaneous tissue disorder |
|
| Nervous system disorders |
|
| Psychiatric disorders |
|
| Gastrointestinal disorders |
|
| Grade 2 TEAEs |
|
| Grade 3 TEAEs |
|
| Grade 4 TEAEs |
|
| AUC0-48 (hr*ng/mL) |
|
| AUC0-72 (hr*ng/mL) |
|
| AUC0-D7 (hr*ng/mL) |
|
| AUC0-D14 (hr*ng/mL) |
|
| AUC0-D28 (hr*ng/mL) |
|