Clinical trial NCT03905265: Dose-finding Study of Moxidectin for Treatment of Scabies
Official title: A Phase II, Randomized, Double-blind, Parallel Group Dose Finding Study of Single Oral Doses of Moxidectin in Adults With Scabies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Scabies
Keywords: moxidectin
acaricide
oral
Lead sponsor: Medicines Development for Global Health
Sponsor class: OTHER
First posted: 2019-04-05
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality Rate for Adult Scabies Mites
timeFrame: 28 days
measure: Summary of Participants With Most Commonly Occurring Adverse Events by Preferred Term (Safety Analysis Set)
timeFrame: Day 0 to Day 28 inclusive
measure: Number of Participants and Severity of Adverse Events
timeFrame: Day 0 to Day 28 inclusive
Secondary outcomes:
measure: Analysis of Moxidectin Plasma Concentrations
timeFrame: 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: Analysis of Moxidectin Maximum Plasma Concentrations (Cmax)
timeFrame: 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 outcomes:
measure: Incidence and Severity of Scabies Signs and Symptoms
timeFrame: 28 days
measure: Severity of Pruritus
timeFrame: 28 days
Locations:
city: Darwin
country: Australia
facility: Royal Darwin Hospital
city: Vienna
country: Austria
facility: Medizinischen Universität Wien
city: Créteil
country: France
facility: Hopital Henri Mondor AP-HP
city: Nice
country: France
facility: CHU Nice Hopital Archet 2
city: Saint-Priest-en-Jarez
country: France
facility: CHU Saint-Etienne Hopital Nord
Study officials:
References: