Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers

October 9, 2014 updated by: Marval Pharma Ltd.

Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers

This is a randomized, double-blind, single dose, dose-escalation study to evaluate the safety, tolerability, and pharmacokinetics of NCTX (PEGylated Liposomal Iodixanol Injection) administered intravenously to healthy volunteers. In addition, computed tomography (CT) scans will be acquired to measure radiographic density in regions of interest (ROI) at times from 3-5 hours and up to 72 hours following NCTX administration.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Quintiles Phase 1 Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy, nonsmoking men and women 18 to 55 years of age
  • Body Mass Index (BMI) between 18.5 and 30.0 kg/m2
  • Serum creatinine within normal range and calculated creatinine clearance of 80 mL/min/1.73 m2 or greater

Exclusion Criteria:

  • Concurrent enrollment in another clinical trial or treatment with any investigational products or therapies within 30 days prior to dosing
  • History of infusion reactions to liposomes, nanoparticles, monoclonal antibodies, or intravenously administered materials
  • History of allergic/anaphylactoid-like reactions attributed to iodinated contrast agents or other components of the formulation
  • Disturbances in normal fat metabolism, or total cholesterol greater than 240 mg/dL
  • Pregnant or nursing women
  • Exposure to significant radiation within 1 year, or previous CT scan within 5 years prior to check-in

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Saline Placebo
2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion
Drug: Saline Placebo
Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug
Experimental: NCTX
6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion
Drug: NCTX (PEGylated Liposomal Iodixanol Injection)
Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg
Other Names:
  • NCTX

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
Time Frame: Baseline and up to and including 28 days post drug administration
Baseline and up to and including 28 days post drug administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol
Time Frame: Baseline and up to 28 days post drug administration
Baseline and up to 28 days post drug administration
Radiographic density in ROIs by abdominal CT imaging
Time Frame: From 3-5 hours and up to 72 hours following NCTX administration
From 3-5 hours and up to 72 hours following NCTX administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Marval Pharma Ltd.

Investigators

  • Principal Investigator: Philip T Leese, MD, Quintiles Phase 1 Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

February 12, 2014

First Submitted That Met QC Criteria

February 12, 2014

First Posted (Estimate)

February 14, 2014

Study Record Updates

Last Update Posted (Estimate)

October 10, 2014

Last Update Submitted That Met QC Criteria

October 9, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MARV2013-CP-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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