Healthy VolunteersPhase 1NCT02063594
Single Dose Safety, Tolerability and Pharmacokinetic Study of NCTX in Healthy Volunteers
A Phase 1 study testing NCTX (PEGylated Liposomal Iodixanol Injection) in people with Healthy Volunteers, run by Marval Pharma Ltd. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- NCTX (PEGylated Liposomal Iodixanol Injection)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Oct 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Quintiles Phase 1 Services
Overland Park, Kansas, 66211
About this study
Official title: 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.
- Conditions
- Healthy Volunteers
- Being tested
- NCTX (PEGylated Liposomal Iodixanol Injection), Saline Placebo
- Keywords
- Iodixanol, Iodinated Contrast, Liposome, Computed Tomography, X-ray Imaging, Blood pool agent, Biomarker
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCTX (PEGylated Liposomal Iodixanol Injection)Drug
Also called NCTX
Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg
Saline PlaceboDrug
Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug
| Study group | Role | What they receive |
|---|---|---|
| Saline Placebo | Placebo comparator | 2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion Receives: Drug: Saline Placebo |
| NCTX | Experimental | 6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion Receives: Drug: NCTX (PEGylated Liposomal Iodixanol Injection) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
Measured: Baseline and up to and including 28 days post drug administration
Secondary outcomes (2)
Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol
Measured: Baseline and up to 28 days post drug administration
Radiographic density in ROIs by abdominal CT imaging
Measured: From 3-5 hours and up to 72 hours following NCTX administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marval Pharma Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Philip T Leese, MD, Principal investigator, Quintiles Phase 1 Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02063594
- Sponsor's protocol ID
- MARV2013-CP-001
- Status last verified
- Oct 2014
- First submitted
- 12 Feb 2014
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Single Dose, Double-blind, Dose-escalation, Safety, Tolerability and Pharmacokinetic Study of NCTX (PEGylated Liposomal Iodixanol Injection) in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02063594
- Acronym / sponsor ID
- MARV2013-CP-001
- Conditions
- Healthy Volunteers
- Keywords
- Iodixanol, Iodinated Contrast, Liposome, Computed Tomography, X-ray Imaging, Blood pool agent, Biomarker
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Marval Pharma Ltd.Industry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 14 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline Placebo | Placebo comparator | Drug: Saline Placebo2 of 8 subjects in each dose cohort will receive normal saline as a single intravenous infusion |
| NCTX | Experimental | Drug: NCTX (PEGylated Liposomal Iodixanol Injection)6 of 8 subjects in each dose cohort will receive NCTX (PEGylated Liposomal Iodixanol Injection) as a single intravenous infusion |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCTX (PEGylated Liposomal Iodixanol Injection)Also: NCTXSingle dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg | Drug | NCTX |
| Saline PlaceboSingle dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug | Drug | Saline Placebo |
Primary outcome
Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring
Time frame: Baseline and up to and including 28 days post drug administration
2 secondary outcomes
Maximum blood concentration (Cmax), half-life (t1/2), and ratio of free to encapsulated circulating iodixanol
Time frame: Baseline and up to 28 days post drug administration
Radiographic density in ROIs by abdominal CT imaging
Time frame: From 3-5 hours and up to 72 hours following NCTX administration
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2014.
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip T Leese, MD principal investigator
Quintiles Phase 1 Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NCTX (PEGylated Liposomal Iodixanol Injection) in people with Healthy Volunteers, run by Marval Pharma Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of safety by clinical laboratory parameters, vital sign measurements, electrocardiograms, and adverse event monitoring (time frame: Baseline and up to and including 28 days post drug administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2014.