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

NCT02063594 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-10-10

No results posted yet for this study

Summary

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.

Conditions

  • Healthy Volunteers

Interventions

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

DRUG

Saline Placebo

Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug

Sponsors & Collaborators

  • Marval Pharma Ltd.

    lead INDUSTRY

Principal Investigators

  • Philip T Leese, MD · Quintiles Phase 1 Services

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2014-10-31
Completion
2014-10-31

Countries

  • United States

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 NCT02063594 on ClinicalTrials.gov