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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saline Placebo | Placebo Comparator | 2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion |
|
| NCTX | Experimental | 6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philip T Leese, MD | Quintiles Phase 1 Services | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quintiles Phase 1 Services | Overland Park | Kansas | 66211 | United States |
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| Saline Placebo | Drug | Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug |
|