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

NCT02063594 | Terminated Phase 1

• 1 other identifier: MARV2013-CP-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Iodixanol; Iodinated Contrast; Liposome; Computed Tomography; X-ray Imaging; Blood pool agent; Biomarker

Outcome Measures

Primary Outcomes (1)

• Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring

  Baseline and up to and including 28 days post drug administration

Secondary Outcomes (2)

• Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol

  Baseline and up to 28 days post drug administration

• Radiographic density in ROIs by abdominal CT imaging

  From 3-5 hours and up to 72 hours following NCTX administration

Study Arms (2)

Saline Placebo

PLACEBO COMPARATOR

2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion

Drug: Saline Placebo

NCTX

EXPERIMENTAL

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)

Interventions

NCTX (PEGylated Liposomal Iodixanol Injection) DRUG

Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg

Also known as: NCTX

NCTX

Saline Placebo DRUG

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

Saline Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marval Pharma Ltd.: lead

Study Sites (1)

Quintiles Phase 1 Services

Overland Park, Kansas, 66211, United States

Location

Study Officials

• Philip T Leese, MD

  Quintiles Phase 1 Services

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: February 14, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

US (1)