Status:
COMPLETED
Relative Bioavailability of CE-Iohexol (Captisol-enabled™ Iohexol) Injection and Omnipaque™ Injection
Lead Sponsor:
CyDex Pharmaceuticals, Inc.
Collaborating Sponsors:
Ligand Pharmaceuticals
Syneos Health
Conditions:
Contrast-induced Nephropathy
Coronary Angiography
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 healt...
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 s...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
April 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03869983
Start Date
April 12 2019
End Date
June 15 2019
Last Update
August 16 2019
Active Locations (1)
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1
Syneos Health Clinique
Québec, Quebec, Canada, G1P0A2