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

Phase 1

Terminated

• Conditions: Healthy Volunteers
• Interventions: Drug: Saline Placebo; Drug: NCTX (PEGylated Liposomal Iodixanol Injection)

• Registration Number: NCT02063594
• Lead Sponsor: Marval Pharma Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-02-12
• Study First Posted: 2014-02-14
• Study Start: 2014-03
• Status Verified: 2014-10
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-09
• Last Update Posted: 2014-10-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline Placebo	Saline Placebo	2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion
NCTX	NCTX (PEGylated Liposomal Iodixanol Injection)	6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Quintiles Phase 1 Services; 🇺🇸 Overland Park, Kansas, United States