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

Marval Pharma

Status and phase: Terminated; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: NCTX (PEGylated Liposomal Iodixanol Injection); Drug: Saline Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02063594

MARV2013-CP-001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups, including a placebo group

Saline Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline Placebo

NCTX

Experimental group

Description:

6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion

Treatment:

Drug: NCTX (PEGylated Liposomal Iodixanol Injection)