EUCTR2019-001775-37-FRActive, not recruitingPhase 1
A Phase II, randomized, double-blind, parallel group dose finding study of single oral doses of moxidectin in adults with scabies
Medicines Development Limited (trading as Medicines Development for Global Health)0 sites18 target enrollmentStarted: July 16, 2019Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 18
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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 (RCM).
- •4. Agree to the use of reliable contraceptive measures if female or male partner of a female of child-bearing potential from Screening until 6 months after treatment with study drug.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
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.
- •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. 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.
- •8. Clinically relevant laboratory abnormalities at Screening, including:
- •a. alanine aminotransferase or aspartate aminotransferase > 2.5 x upper limit of reference range;
- •b. creatinine > 2.0 milligrams per deciliter (mg/dL);
- •c. hemoglobin < 9.5 g/dL (female) or <10.5 g/dL (male);
- •d. amylase > 2.0 x upper limit of reference range.
- •9. Known or suspected hypersensitivity to macrocyclic lactones or excipients used in the formulation of moxidectin.
- •10. Use of systemic steroids within 14 days of Screening, or history of prolonged use of systemic and/or high-dose inhaled corticosteroids.
- •11. Subjects with known or suspected Loa loa coinfection.
- •12. Received a vaccination within 28 days of Baseline.
- •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.
Investigators
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