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A Phase I Clinical Study on a New Oral Pentamidine Formulation in Hepatocellular Carcinoma

NCT02210182 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2016-03-14

No results posted yet for this study

Summary

The purpose of this study is to investigate on the Hepatic Uptake, Pharmacokinetics, Safety and Tolerance of a New Oral Pentamidine Formulation in Hepatocellular Carcinoma Subjects Undergoing Thermal Ablation

Conditions

Interventions

DRUG

Oral Pentamidine

Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

OTHER

Placebo

Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days

Sponsors & Collaborators

  • Oncozyme Pharma Inc.

    lead INDUSTRY

Principal Investigators

  • Patrick Colin, B.Pharm, PhD · Verlyx Pharma Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

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 NCT02210182 on ClinicalTrials.gov