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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02063594
• Other study ID #: MARV2013-CP-001
• Status: Terminated
• Phase: Phase 1
• First received: February 12, 2014
• Last updated: October 9, 2014
• Start date: March 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Marval Pharma Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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

Locations

Country	Name	City	State
United States	Quintiles Phase 1 Services	Overland Park	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Marval Pharma Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	Radiographic density in ROIs by abdominal CT imaging		From 3-5 hours and up to 72 hours following NCTX administration	No