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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Tolerance and Pharmacokinetics Study of MNTX Tablets

NCT01366339

Normal Healthy Volunteers

COMPLETED PHASE1

Study to Assess the Safety, Tolerability, and Pharmacokinetics of INCB000631 When Administered Orally to Healthy Adult Participants

NCT07039929

Healthy Participants

TERMINATED PHASE1

A Phase 1 Study of Subcutaneous CDX-0159 in Healthy Subjects

NCT05031624

Healthy Subjects

COMPLETED PHASE1

Study of Pharmacokinetics, Safety and Tolerability of Intravenous Methylnaltrexone Bromide

NCT01366365

Healthy Adults

COMPLETED PHASE1

Single and Multiple Ascending Dose Study of ADX-914 in Healthy Adult Volunteers

NCT04485481

Safety Issues

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Saline Placebo

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

Group Type PLACEBO_COMPARATOR

Saline Placebo

Intervention Type DRUG

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

NCTX

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

Group Type EXPERIMENTAL

NCTX (PEGylated Liposomal Iodixanol Injection)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DRUG

Saline Placebo

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

NCTX

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes