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

PHASE1TerminatedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

October 31, 2014

Study Completion Date

October 31, 2014

Conditions
Healthy Volunteers
Interventions
DRUG

NCTX (PEGylated Liposomal Iodixanol Injection)

Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg

DRUG

Saline Placebo

Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug

Trial Locations (1)

66211

Quintiles Phase 1 Services, Overland Park

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Marval Pharma Ltd.

INDUSTRY