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

A Phase 2, Randomized, Unicentric Clinical Trial With Dose Scaling for Safety, Tolerability and Efficacy Assessment of 18-Methoxycoronaridine Administered to Cutaneous Leishmaniasis Patients

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Leishmaniasis; American, Cutaneous; Drug Side Effect
• Intervention / Treatment: Drug: 18-Methoxycoronaridine; Drug: Glucantime

• Study Type: Interventional
• Enrollment (Anticipated): 52
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Jan Carlo Delorenzi, PhD; Phone Number: +55(11)989780869; Email: jancarlo@hebron.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1 mg/day	Drug: 18-Methoxycoronaridine; Drug under evaluation for leishmaniasis treatment
Experimental: 4 mg/day	Drug: 18-Methoxycoronaridine; Drug under evaluation for leishmaniasis treatment
Experimental: 8 mg/day	Drug: 18-Methoxycoronaridine; Drug under evaluation for leishmaniasis treatment
Experimental: 12 mg/day	Drug: 18-Methoxycoronaridine; Drug under evaluation for leishmaniasis treatment
Active Comparator: Glucantime	Drug: Glucantime; Leishmaniasis standard drug in Brazil
Experimental: Best dose 18-MC	Drug: 18-Methoxycoronaridine; Drug under evaluation for leishmaniasis treatment
Experimental: Minimum effective dose 18-MC	Drug: 18-Methoxycoronaridine; Drug under evaluation for leishmaniasis treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lesion Reduction and Re-epithelization - Definitive Cure	complete epithelization of all ulcers and complete disappearance of inflammatory hardening of all lesions at 6 months at the follow-up visit.	6 months at the follow-up visit.
Lesion Reduction and Re-epithelization - Partial Cure	incomplete epithelialization or incomplete regression of inflammatory hardening of one or more lesions, and without the appearance of new lesions. Apparent cure: complete epithelization of all ulcers and regression ≥ 70% of the inflammatory hardening of all lesions.	6 months at the follow-up visit.
Clinical Failure	Any of the following topics as clinical failure: residual readers with the presence of non-GiemsaDiff-Quick print parasites, or the appearance of new lesions or ≥ 20% increase or no improvement of lesions previously documented.	6 months at the follow-up visit.

Collaborators and Investigators

• Sponsor: Infan Industria Quimica Farmaceutica Nacional

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: March 14, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: safety; pharmacokynetics; leishmaniasis treatment
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Skin Diseases; Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Skin Diseases, Parasitic; Skin Diseases, Infectious; Euglenozoa Infections; Drug-Related Side Effects and Adverse Reactions; Leishmaniasis; Leishmaniasis, Cutaneous; Anti-Infective Agents; Antiprotozoal Agents; Antiparasitic Agents; Meglumine Antimoniate
• Other Study ID Numbers: HB/F2-002/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No