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Pharmacokinetic Drug-Drug Interaction Study

NCT03892213 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-03-27

No results posted yet for this study

Summary

The purpose of this study is to determine whether benznidazole and E1224 should be administered concomitantly in patients with Chagas Disease as not enough data are available. This study aims to assess cross interactions of these two compounds.

Conditions

  • Chagas Disease

Interventions

DRUG

Benznidazole

Benznidazole single dose (2.5 mg/kg) at Day 1. Benznidazole single dose (2.5 mg/kg) at Day 9\*. Benznidazole multiple dose (2.5 mg/kg twice daily) from Day 12\* until Day 15.

DRUG

E1224

E1224 multiple dose 400 mg loading dose once daily for 3 days (i.e. from Day 4 to Day 6 followed by maintenance dose 100mg once daily for 9 days (from Day 7 to Day15). On Day 9 and from Day 12 to Day 15, E1224 and benznidazole will be given concomitantly.

Sponsors & Collaborators

  • PhinC Development

    collaborator INDUSTRY

  • Drugs for Neglected Diseases

    lead OTHER

Principal Investigators

  • Isabela Ribeiro, MD · Drugs for Neglected Diseases initiative

  • Ethel Feleder, MD · F.P. Clinical Pharma Clinical Research Unit

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2014-12-31
Completion
2015-01-31

Countries

  • Argentina

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03892213 on ClinicalTrials.gov