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

I

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)

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

Trial contacts and locations

0

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Central trial contact

Jan Carlo Delorenzi, PhD

Data sourced from clinicaltrials.gov

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