drugset / Trial / NCT02063594

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

NCT02063594 ↗

Phase 1 Terminated 20 enrolled Marval Pharma Ltd.
RandomizedParallel-groupQuadruple-blindDiagnostic

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.

Timeline

Start
2014-03
Primary completion
2014-10
Completion
2014-10

Drugs

EvaluationDrugModalityDoseRoute
Subject NCTX Unknown 9 mg/kg Intravenous
Subject NCTX Unknown 110 mg/kg Intravenous

Indications

No indication recorded.