Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 11/8/2014 |
| Start Date: | March 2014 |
| End Date: | June 2014 |
| Contact: | Karen MacLeod |
| Email: | karen.macleod@marvalpharma.com |
| Phone: | 207-452-2039 |
Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers
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.
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.
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
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