Scabies
Conditions
Keywords
moxidectin, acaricide, oral
Brief summary
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.
Interventions
The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
Sponsors
Medicines Development for Global Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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).
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged ≥ 18 years. 2. Provision of written informed consent. 3. Parasitologically confirmed active Sarcoptes scabiei infestation, defined as the presence of at least two lesions (which may include burrows), each containing at least one live (internal and/or external structures discernable) adult Sarcoptes scabiei mite observed by reflectance confocal microscopy. 4. Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening and until 6 months after treatment with study product.
Exclusion criteria
1. History of chronic or recurring dermatologic disease (other than scabies) that could interfere with the diagnosis and/or subsequent clinical assessment of scabies. 2. 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). 3. 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. 4. 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. 5. Poor venous access. 6. Received an investigational agent within 28 days of Screening (or 5 half-lives of the investigational agent, whichever is longer). 7. Body Mass Index over 35 kg/m2. 8. 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. 9. Clinically relevant laboratory abnormalities at Screening, including: 1. alanine aminotransferase or aspartate aminotransferase \> 2.5 x upper limit of reference range; 2. creatinine \> 2.0 milligrams per deciliter (mg/dL); 3. hemoglobin \< 9.5 g/dL (female) or \<10.5 g/dL (male); 4. amylase \> 2.0 x upper limit of reference range. 10. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin. 11. 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. 12. Subjects with known or suspected Loa loa coinfection. 13. Difficulty swallowing tablets. 14. Pregnant or breastfeeding, or planning to become pregnant. 15. Known or suspected alcohol or illicit substance abuse. 16. Unwilling, unlikely or unable to comply with all protocol specified assessments. 17. Previous enrolment and treatment with moxidectin in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Day 0 to Day 28 inclusive | 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. |
| Mortality Rate for Adult Scabies Mites | 28 days | 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. |
| Number of Participants and Severity of Adverse Events | Day 0 to Day 28 inclusive | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | 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 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). |
| Analysis of Moxidectin Plasma Concentrations | 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 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidence and Severity of Scabies Signs and Symptoms | 28 days | The incidence and severity of signs and symptoms of scabies infection will be explored using a clinician-reported scabies severity assessment. |
| Severity of Pruritus | 28 days | The severity of pruritus will be determined using the Numerical Rating Scale where 0=no itch and 10=worst itch imaginable |
Countries
Australia, Austria, France
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 4 |
| 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 | 4 |
| 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 | 6 |
| Moxidectin 36 mg 8 Participants received Moxidectin 36 mg as a single dose.
Moxidectin Oral Product: 36 mg oral tablets | 8 |
| Total | 22 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Total | Moxidectin 2 mg | Moxidectin 8 mg | Moxidectin 36 mg | Moxidectin 20 mg |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 1 Participants | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 19 Participants | 3 Participants | 3 Participants | 7 Participants | 6 Participants |
| Age, Continuous | 34.8 years STANDARD_DEVIATION 16.73 | 46.5 years STANDARD_DEVIATION 18.88 | 45.3 years STANDARD_DEVIATION 15.5 | 29.4 years STANDARD_DEVIATION 17.26 | 27.2 years STANDARD_DEVIATION 9.33 |
| Body Mass Index | 27.01 kg/m^2 STANDARD_DEVIATION 7.68 | 32.98 kg/m^2 STANDARD_DEVIATION 9.95 | 25.27 kg/m^2 STANDARD_DEVIATION 2.4 | 28.68 kg/m^2 STANDARD_DEVIATION 8.46 | 21.70 kg/m^2 STANDARD_DEVIATION 2.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 2 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 17 Participants | 2 Participants | 3 Participants | 8 Participants | 4 Participants |
| Sex: Female, Male Female | 13 Participants | 4 Participants | 1 Participants | 4 Participants | 4 Participants |
| Sex: Female, Male Male | 9 Participants | 0 Participants | 3 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 | 0 / 6 | 0 / 8 |
| other Total, other adverse events | 4 / 4 | 4 / 4 | 6 / 6 | 8 / 8 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 | 0 / 6 | 1 / 8 |
Outcome results
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.
Time frame: 28 days
Population: Per protocol analysis set
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-8 hours timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 28 timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 2 timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 1 timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 14 timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-4 hours timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of live adult mites assessed at Baseline | 2 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 7 timepoint | 0 Adult mites |
| Moxidectin 2 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 3 timepoint | 0 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 7 timepoint | 4 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of live adult mites assessed at Baseline | 6 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-4 hours timepoint | 0 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-8 hours timepoint | 1 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 1 timepoint | 2 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 2 timepoint | 2 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 3 timepoint | 2 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 14 timepoint | 5 Adult mites |
| Moxidectin 8 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 28 timepoint | 6 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of live adult mites assessed at Baseline | 8 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 2 timepoint | 1 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 3 timepoint | 2 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-4 hours timepoint | 0 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 7 timepoint | 4 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 28 timepoint | 8 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 14 timepoint | 8 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 1 timepoint | 0 Adult mites |
| Moxidectin 20 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-8 hours timepoint | 0 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 7 timepoint | 9 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of live adult mites assessed at Baseline | 14 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 2 timepoint | 2 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-4 hours timepoint | 0 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 28 timepoint | 14 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 14 timepoint | 12 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 3 timepoint | 3 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 1 timepoint | 0 Adult mites |
| Moxidectin 36 mg | Mortality Rate for Adult Scabies Mites | Number of dead adult mites assessed at Day 0-8 hours timepoint | 0 Adult mites |
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.
Time frame: Day 0 to Day 28 inclusive
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Moxidectin 2 mg | Number of Participants and Severity of Adverse Events | Grade 1 TEAEs | 1 Participants |
| Moxidectin 2 mg | Number of Participants and Severity of Adverse Events | Grade 2 TEAEs | 3 Participants |
| Moxidectin 2 mg | Number of Participants and Severity of Adverse Events | Grade 3 TEAEs | 0 Participants |
| Moxidectin 2 mg | Number of Participants and Severity of Adverse Events | Grade 4 TEAEs | 0 Participants |
| Moxidectin 8 mg | Number of Participants and Severity of Adverse Events | Grade 2 TEAEs | 3 Participants |
| Moxidectin 8 mg | Number of Participants and Severity of Adverse Events | Grade 3 TEAEs | 0 Participants |
| Moxidectin 8 mg | Number of Participants and Severity of Adverse Events | Grade 4 TEAEs | 0 Participants |
| Moxidectin 8 mg | Number of Participants and Severity of Adverse Events | Grade 1 TEAEs | 1 Participants |
| Moxidectin 20 mg | Number of Participants and Severity of Adverse Events | Grade 3 TEAEs | 0 Participants |
| Moxidectin 20 mg | Number of Participants and Severity of Adverse Events | Grade 2 TEAEs | 2 Participants |
| Moxidectin 20 mg | Number of Participants and Severity of Adverse Events | Grade 4 TEAEs | 0 Participants |
| Moxidectin 20 mg | Number of Participants and Severity of Adverse Events | Grade 1 TEAEs | 4 Participants |
| Moxidectin 36 mg | Number of Participants and Severity of Adverse Events | Grade 4 TEAEs | 0 Participants |
| Moxidectin 36 mg | Number of Participants and Severity of Adverse Events | Grade 2 TEAEs | 3 Participants |
| Moxidectin 36 mg | Number of Participants and Severity of Adverse Events | Grade 1 TEAEs | 5 Participants |
| Moxidectin 36 mg | Number of Participants and Severity of Adverse Events | Grade 3 TEAEs | 0 Participants |
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.
Time frame: Day 0 to Day 28 inclusive
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Moxidectin 2 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Gastrointestinal disorders | 0 Participants |
| Moxidectin 2 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Psychiatric disorders | 2 Participants |
| Moxidectin 2 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Infections and infestations | 3 Participants |
| Moxidectin 2 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Skin and subcutaneous tissue disorder | 1 Participants |
| Moxidectin 2 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Nervous system disorders | 2 Participants |
| Moxidectin 8 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Nervous system disorders | 0 Participants |
| Moxidectin 8 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Infections and infestations | 3 Participants |
| Moxidectin 8 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Skin and subcutaneous tissue disorder | 2 Participants |
| Moxidectin 8 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Psychiatric disorders | 0 Participants |
| Moxidectin 8 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Gastrointestinal disorders | 1 Participants |
| Moxidectin 20 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Psychiatric disorders | 1 Participants |
| Moxidectin 20 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Gastrointestinal disorders | 1 Participants |
| Moxidectin 20 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Skin and subcutaneous tissue disorder | 1 Participants |
| Moxidectin 20 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Nervous system disorders | 1 Participants |
| Moxidectin 20 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Infections and infestations | 5 Participants |
| Moxidectin 36 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Gastrointestinal disorders | 0 Participants |
| Moxidectin 36 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Infections and infestations | 5 Participants |
| Moxidectin 36 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Nervous system disorders | 3 Participants |
| Moxidectin 36 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Psychiatric disorders | 0 Participants |
| Moxidectin 36 mg | Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set) | Skin and subcutaneous tissue disorder | 4 Participants |
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).
Time frame: 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)
Population: Cmax was calculated and derived using non-compartmental methods.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Moxidectin 2 mg | Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | 21.0 Cmax (ng/mL) | Geometric Coefficient of Variation 47.1 |
| Moxidectin 8 mg | Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | 73.5 Cmax (ng/mL) | Geometric Coefficient of Variation 42 |
| Moxidectin 20 mg | Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | 207 Cmax (ng/mL) | Geometric Coefficient of Variation 44.9 |
| Moxidectin 36 mg | Analysis of Moxidectin Maximum Plasma Concentrations (Cmax) | 277 Cmax (ng/mL) | Geometric Coefficient of Variation 26.9 |
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).
Time frame: 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)
Population: Pharmacokinetic parameters were calculated and derived using non-compartmental methods. AUC calculation method was linear up log down.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Moxidectin 2 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-24 (hr*ng/mL) | 181 hr*ng/mL | Geometric Coefficient of Variation 43.2 |
| Moxidectin 2 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-48 (hr*ng/mL) | 212 hr*ng/mL | Geometric Coefficient of Variation 44.2 |
| Moxidectin 2 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-72 (hr*ng/mL) | 229 hr*ng/mL | Geometric Coefficient of Variation 45.5 |
| Moxidectin 2 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D7 (hr*ng/mL) | 276 hr*ng/mL | Geometric Coefficient of Variation 50.6 |
| Moxidectin 2 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D14 (hr*ng/mL) | 329 hr*ng/mL | Geometric Coefficient of Variation 62.8 |
| Moxidectin 2 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D28 (hr*ng/mL) | 408 hr*ng/mL | Geometric Coefficient of Variation 82.5 |
| Moxidectin 8 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D28 (hr*ng/mL) | 1970 hr*ng/mL | Geometric Coefficient of Variation 30 |
| Moxidectin 8 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D7 (hr*ng/mL) | 1230 hr*ng/mL | Geometric Coefficient of Variation 30.5 |
| Moxidectin 8 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-24 (hr*ng/mL) | 744 hr*ng/mL | Geometric Coefficient of Variation 37.9 |
| Moxidectin 8 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-72 (hr*ng/mL) | 989 hr*ng/mL | Geometric Coefficient of Variation 33.7 |
| Moxidectin 8 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-48 (hr*ng/mL) | 903 hr*ng/mL | Geometric Coefficient of Variation 35 |
| Moxidectin 8 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D14 (hr*ng/mL) | 1540 hr*ng/mL | Geometric Coefficient of Variation 27.9 |
| Moxidectin 20 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-48 (hr*ng/mL) | 2000 hr*ng/mL | Geometric Coefficient of Variation 40.7 |
| Moxidectin 20 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-72 (hr*ng/mL) | 2200 hr*ng/mL | Geometric Coefficient of Variation 40.4 |
| Moxidectin 20 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D7 (hr*ng/mL) | 2780 hr*ng/mL | Geometric Coefficient of Variation 39.5 |
| Moxidectin 20 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D28 (hr*ng/mL) | 4670 hr*ng/mL | Geometric Coefficient of Variation 41.1 |
| Moxidectin 20 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D14 (hr*ng/mL) | 3530 hr*ng/mL | Geometric Coefficient of Variation 39.3 |
| Moxidectin 20 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-24 (hr*ng/mL) | 1670 hr*ng/mL | Geometric Coefficient of Variation 40.2 |
| Moxidectin 36 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D14 (hr*ng/mL) | 5820 hr*ng/mL | Geometric Coefficient of Variation 38.1 |
| Moxidectin 36 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D28 (hr*ng/mL) | 7430 hr*ng/mL | Geometric Coefficient of Variation 37.6 |
| Moxidectin 36 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-48 (hr*ng/mL) | 3560 hr*ng/mL | Geometric Coefficient of Variation 29.3 |
| Moxidectin 36 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-D7 (hr*ng/mL) | 4770 hr*ng/mL | Geometric Coefficient of Variation 35.1 |
| Moxidectin 36 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-24 (hr*ng/mL) | 2930 hr*ng/mL | Geometric Coefficient of Variation 26.8 |
| Moxidectin 36 mg | Analysis of Moxidectin Plasma Concentrations | AUC0-72 (hr*ng/mL) | 3900 hr*ng/mL | Geometric Coefficient of Variation 31 |
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.
Time frame: 28 days
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
Time frame: 28 days