Contrast-induced NephropathyNCT03869983
Relative Bioavailability of CE-Iohexol (Captisol-enabled™ Iohexol) Injection and Omnipaque™ Injection
A study testing Omnipaque™ (iohexol) Injection and CE-Iohexol in people with Contrast-induced Nephropathy and Coronary Angiography, run by CyDex Pharmaceuticals, Inc. at 1 site in Canada.
Trial summary
This study is designed to compare the bioavailability of the test Product(CE-Iohexol Injection) and the reference product Iohexol Injection (Omnipaque™) following intravenous injection in normal healthy volunteers. The secondary objective is to assess the safety and tolerability of the treatments administered. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Contrast-induced Nephropathy, Coronary Angiography
- What is being tested?
- Omnipaque™ (iohexol) Injection and CE-Iohexol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteCanada
- Study dates
- 12 Apr 2019to 15 Jun 2019
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women of childbearing potential who are sexually active with a non-sterile male partner must be using a medically acceptable form of birth control for the duration of the trial and for 30 days after the last dose of study drug
- BMI within the range of 18.5-35 kg/m2, inclusive, and body weight > 45 kg
- No significant disease or abnormal laboratory values
- Normal vital signs, without any clinically significant abnormalities
- Normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction
- Nonsmokers defined as not having smoked in the past 3 months prior to dosing
- Estimated glomerular filtration rate (eGFR) of > 60 mL/min/1.73 m2
Who cannot join
- Known hypersensitivity or allergy to iohexol, CAPTISOL®, Omnipaque™ or its excipients
- Known hypersensitivity or allergy to iodine or radio-opaque dyes
- Women who are pregnant or breast feeding
- History or presence of asthma or other pulmonary disease, thyroid disease (hypo- or hyperthyroidism), hepatitis or other liver disease
- Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise a major system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
- Abnormal laboratory values which are considered clinically significant
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- Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2)
- Participation in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dose
- Use of medication other than topical products without significant systemic absorption, hormonal contraceptives and hormone replacement therapy
- Unwilling to refrain from consumption of alcohol within 48 hours prior to each dose administration and during any in-patient period.
- Positive urine drug screen, positive alcohol breath test or positive cotinine test at screening and upon check-in to the study facility
- History of significant alcohol abuse within one year prior to screening or regular use of alcohol within six months prior to the screening visit
- Illicit drug use,significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction
- A history of difficulty with donating blood or with the insertion of large-calibre catheter
- Donation of plasma (500 mL) within 7 days prior to drug administration.
- Hemoglobin < 128 g/L (males) and < 115 g/L (females) and hematocrit < 0.36 L/L (males) and < 0.32 L/L (females) at screening
- Any history of photosensitivity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, 2-Period Crossover Trial to Determine the Relative Bioavailability of CE-Iohexol (Iohexol/Sulfobutylether-β-Cyclodextrin ( Captisol®)) Injection and Omnipaque™ (Iohexol) Injection in Healthy Adult Volunteers
This study is designed to compare the bioavailability of the test Product(CE-Iohexol Injection) and the reference product Iohexol Injection (Omnipaque™) following intravenous injection in normal healthy volunteers. The secondary objective is to assess the safety and tolerability of the treatments administered. Captisol® is present to improve stability and to potentially reduce the risk of contrast-induced acute kidney injury(CI-AKI) associated with iohexol administration.
Read the detailed description
This is a single center, randomized, double-blind, 2-period, crossover study. A total of 24 subjects will be enrolled in the study; subjects will be dosed as 2 groups of 12 subjects each. Additional subjects may be enrolled into the study to obtain the statistical power of 90%. Subjects will attend a screening visit within 28 days prior to Period 1, and eligible subjects will then return to the clinic on the evening prior to Day -1. On Day 1, prior to dosing, subjects will be randomized to receive either CE-Iohexol Injection or the reference product during the first treatment period and the alternate product during the second treatment period. In each period, the study drug will be administered after a fasting period ≥8 hours. Each dose of intravenous iohexol will be separated by a minimum of a 7-day washout period. The test or reference product (iohexol 350 mg Iodine/mL, 80 mL) will be infused at a high flow rate of 4 mL/second for a dose of 400 mgI/kg for 70 kg subject. The test or reference product will be administered using a power injector. Plasma samples for determination of iohexol concentrations will be obtained from arm #2 (the arm not used for dosing) at 0 (pre-dose), 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours after infusion start; the 30-second sample obtained at the end of infusion. Subjects will be discharged from the clinic on Day 3 following collection of the 48-hour blood sample.
- Conditions
- Contrast-induced Nephropathy, Coronary Angiography
- Being tested
- Omnipaque™ (iohexol) Injection, CE-Iohexol
- Keywords
- Iohexol, Captisol®, cyclodextrin, radiographic, iodinated contrast medium, Omnipaque™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omnipaque™ (iohexol) InjectionOther
755 mg/mL iohexol (350 mgI/mL), 80 mL infused intravenously over approximately 20 seconds
CE-IohexolOther
755 mg/mL iohexol (350 mgI/mL)/50 mg CAPTISOL®/mL, 80 mL infused intravenously over approximately 20 seconds
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator | Active comparator | Omnipaque™ (iohexol) Injection, 755 mg/mL iohexol (350 mgI/mL) Receives: Other: Omnipaque™ (iohexol) Injection |
| Experimental | Experimental | CE-Iohexol Injection, 755 mg/mL iohexol (350 mgI/mL)/50 mg CAPTISOL®/mL Receives: Other: CE-Iohexol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Iohexol Area Under the Concentration-Time Curve (AUC) [ Time Frame: At designated time points up to 48 hours per Period ]
Blood samples are to be collected at designated time points for the determination of the iohexol AUC. (Time points for CE-Iohexol Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose. Time points for Omnipaque™ (iohexol) Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose).
Measured: 48 hours
Iohexol Maximum Plasma Concentration (Cmax) [ Time Frame: At designated time points up to 48 hours per Period ]
Blood samples are to be collected at designated time points for the determination of the iohexol Cmax. (Time points for CE-Iohexol Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose. Time points for Omnipaque™ (iohexol) Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose).
Measured: 48 hours
Secondary outcomes (1)
Severity of all Adverse Events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) [Time Frame: Day -1, 24h and 48h post dose].
An adverse event is defined as any untoward medical occurrence in a clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. The severity of all adverse events will be graded according to the CTCAE version 4.0 from dosing until 30 days post-dose
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start12 Apr 2019
- Primary completion15 May 2019
- Study completion15 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Contrast-induced NephropathyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single center, randomized, double-blind, 2-period, crossover study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- CyDex Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ligand Pharmaceuticals, Syneos Health
- Responsible party
- Sponsor
- Investigators
- Keith Marschke, PhD, Study director, Ligand Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03869983
- Sponsor's protocol ID
- CE-Iohexol Protocol -101
- Other IDs
- Study Number-1802282
- Status last verified
- Mar 2019
- First submitted
- 7 Mar 2019
- Last updated
- 16 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, 2-Period Crossover Trial to Determine the Relative Bioavailability of CE-Iohexol (Iohexol/Sulfobutylether-β-Cyclodextrin ( Captisol®)) Injection and Omnipaque™ (Iohexol) Injection in Healthy Adult Volunteers
- ClinicalTrials.gov ID
- NCT03869983
- Acronym / sponsor ID
- CE-Iohexol Protocol -101
- Conditions
- Contrast-induced Nephropathy, Coronary Angiography
- Keywords
- Iohexol, Captisol®, cyclodextrin, radiographic, iodinated contrast medium, Omnipaque™
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- CyDex Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Ligand Pharmaceuticals, Syneos Health
- Study start
- 12 Apr 2019 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- 15 Jun 2019 (actual)
- First posted
- 11 Mar 2019 (actual)
- 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 study is designed to compare the bioavailability of the test Product(CE-Iohexol Injection) and the reference product Iohexol Injection (Omnipaque™) following intravenous injection in normal healthy volunteers. The secondary objective is to assess the safety and tolerability of the treatments administered. Captisol® is present to improve stability and to potentially reduce the risk of contrast-induced acute kidney injury(CI-AKI) associated with iohexol administration.
Detailed description
This is a single center, randomized, double-blind, 2-period, crossover study. A total of 24 subjects will be enrolled in the study; subjects will be dosed as 2 groups of 12 subjects each. Additional subjects may be enrolled into the study to obtain the statistical power of 90%. Subjects will attend a screening visit within 28 days prior to Period 1, and eligible subjects will then return to the clinic on the evening prior to Day -1. On Day 1, prior to dosing, subjects will be randomized to receive either CE-Iohexol Injection or the reference product during the first treatment period and the alternate product during the second treatment period. In each period, the study drug will be administered after a fasting period ≥8 hours. Each dose of intravenous iohexol will be separated by a minimum of a 7-day washout period. The test or reference product (iohexol 350 mg Iodine/mL, 80 mL) will be infused at a high flow rate of 4 mL/second for a dose of 400 mgI/kg for 70 kg subject. The test or reference product will be administered using a power injector. Plasma samples for determination of iohexol concentrations will be obtained from arm #2 (the arm not used for dosing) at 0 (pre-dose), 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24, and 48 hours after infusion start; the 30-second sample obtained at the end of infusion. Subjects will be discharged from the clinic on Day 3 following collection of the 48-hour blood sample.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Single center, randomized, double-blind, 2-period, crossover study
| Arm | Type | Receives |
|---|---|---|
| Active Comparator | Active comparator | Other: Omnipaque™ (iohexol) InjectionOmnipaque™ (iohexol) Injection, 755 mg/mL iohexol (350 mgI/mL) |
| Experimental | Experimental | Other: CE-IohexolCE-Iohexol Injection, 755 mg/mL iohexol (350 mgI/mL)/50 mg CAPTISOL®/mL |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Women of childbearing potential who are sexually active with a non-sterile male partner must be using a medically acceptable form of birth control for the duration of the trial and for 30 days after the last dose of study drug
- BMI within the range of 18.5-35 kg/m2, inclusive, and body weight > 45 kg
- No significant disease or abnormal laboratory values
- Normal vital signs, without any clinically significant abnormalities
- Normal 12-lead electrocardiogram, without any clinically significant abnormalities of rate, rhythm or conduction
Key exclusion criteria (17 listed)
- Known hypersensitivity or allergy to iohexol, CAPTISOL®, Omnipaque™ or its excipients
- Known hypersensitivity or allergy to iodine or radio-opaque dyes
- Women who are pregnant or breast feeding
- History or presence of asthma or other pulmonary disease, thyroid disease (hypo- or hyperthyroidism), hepatitis or other liver disease
- Any disease or condition (medical or surgical) which, in the opinion of the investigator, might compromise a major system; or other conditions that may interfere with the absorption, distribution, metabolism or excretion of study drug, or would place the subject at increased risk
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 |
|---|---|---|
| Omnipaque™ (iohexol) Injection755 mg/mL iohexol (350 mgI/mL), 80 mL infused intravenously over approximately 20 seconds | Other | Active Comparator |
| CE-Iohexol755 mg/mL iohexol (350 mgI/mL)/50 mg CAPTISOL®/mL, 80 mL infused intravenously over approximately 20 seconds | Other | Experimental |
Primary outcome
Iohexol Area Under the Concentration-Time Curve (AUC) [ Time Frame: At designated time points up to 48 hours per Period ]
Time frame: 48 hours
Blood samples are to be collected at designated time points for the determination of the iohexol AUC. (Time points for CE-Iohexol Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose. Time points for Omnipaque™ (iohexol) Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose).
Iohexol Maximum Plasma Concentration (Cmax) [ Time Frame: At designated time points up to 48 hours per Period ]
Time frame: 48 hours
Blood samples are to be collected at designated time points for the determination of the iohexol Cmax. (Time points for CE-Iohexol Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose. Time points for Omnipaque™ (iohexol) Injection: Pre-dose, 30 seconds, 5, 10, 15, 20, 30 and 45 minutes, and 1, 2, 3, 4, 6, 8, 12, 24 and 48 hrs post dose).
1 secondary outcome
Severity of all Adverse Events graded according to the Common Terminology Criteria for Adverse Events (CTCAE) [Time Frame: Day -1, 24h and 48h post dose].
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2019.
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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.
Keith Marschke, PhD study director
Ligand Pharmaceuticals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Omnipaque™ (iohexol) Injection and CE-Iohexol in people with Contrast-induced Nephropathy and Coronary Angiography, run by CyDex Pharmaceuticals, Inc. at 1 site in Canada.
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 7 inclusion and 17 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: finished, as of the sponsor's last update on 16 Aug 2019. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Iohexol Area Under the Concentration-Time Curve (AUC) [ Time Frame: At designated time points up to 48 hours per Period ] (time frame: 48 hours). The study lists 2 primary outcomes in all. 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 16 Aug 2019.