Dose-finding study of moxidectin for the treatment of scabies

Phase 1

• Conditions: Scabies (infection with Sarcoptes scabiei); MedDRA version: 20.1Level: LLTClassification code 10039511Term: ScabiesSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2019-001775-37-FR
• Lead Sponsor: Medicines Development Limited (trading as Medicines Development for Global Health)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-07-16
• Last Update Posted: 9 May 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified