Phase 2 Trial to Evaluate 18-Methoxycoronaridine Efficacy, Safety and Tolerability in Cutaneous Leishmaniasis Patients

Infan Industria Quimica Farmaceutica Nacional

Status and phase: Not yet enrolling; Phase 2

Conditions: Drug Side Effect; Leishmaniasis; American, Cutaneous

Treatments: Drug: 18-Methoxycoronaridine; Drug: Glucantime

Study type: Interventional

Funder types: Industry

Identifiers

NCT03084952

HB/F2-002/2016

Details and patient eligibility

About

It is a randomized phase II clinical study, unicentre aimed to evaluate the tolerability, safety and efficacy of 18-Methoxyoronaridine as a candidate of tegumentary leishmaniasis treatment.

Enrollment: 52 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 59 years of age;
• Clinical diagnosis of leishmaniasis with at least one ulcerated lesion with evolution time from one month;
• Parasitological confirmation;
• Women of childbearing potential should not be pregnant or breastfeeding, confirmed by examination of b-HCG (Gonadotrophic-Chorionic Hormone beta) at the time of screening;
• Men and women should use barrier contraceptive methods during the course of the study;

Exclusion criteria

• History of any disease or comorbidities that, in the opinion of the investigator, can either put the individual at risk or influence the results and ability of the subject to participate in the study;
• History or presence of gastrointestinal, hepatic, cardiac, renal disease or any other known condition that may interfere with the absorption, distribution, metabolism or excretion of the investigational product;
• Any evidence of underlying serious disease (cardiac, renal, hepatic or pulmonary);
• Pregnancy or the patient's unwillingness to use barrier contraceptive methods during and 3 months after therapy;
• History of gastrointestinal ulcer disease, inflammatory bowel disease, symptoms of indigestion;
• Any clinically important abnormality in biochemistry, hematology, urinalysis or clinical outcomes judged by the investigator;
• Any positive screening result for hepatitis B antigens, hepatitis C antibodies, and human immunodeficiency virus (HIV);
• Any clinically significant abnormalities in the rate, or driving the resting ECG morphology that may interfere with the interpretation of the QT interval variations;
• History of cancer;
• History of drug abuse, judging by the investigator
• History of alcohol abuse or excessive alcohol consumption, judged by the investigator;
• History of smoking
• History of severe allergy / hypersensitivity, judged by the investigator;
• History of hypersensitivity to drugs with similar chemical structure.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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52 participants in 7 patient groups

1 mg/day

Experimental group

Treatment:

Drug: 18-Methoxycoronaridine

4 mg/day

Experimental group

Treatment:

Drug: 18-Methoxycoronaridine

8 mg/day

Experimental group

Treatment:

Drug: 18-Methoxycoronaridine

12 mg/day

Experimental group

Treatment:

Drug: 18-Methoxycoronaridine

Glucantime

Active Comparator group

Treatment:

Drug: Glucantime

Best dose 18-MC

Experimental group

Treatment:

Drug: 18-Methoxycoronaridine

Minimum effective dose 18-MC

Experimental group

Treatment:

Drug: 18-Methoxycoronaridine