Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types

Exclusion Criteria

• •Main Criteria for Exclusion (QuantumLeap device)
• •Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
• •Intolerant to venipuncture
• •Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
• •Participation in another interventional trial within 30 days of screening or concurrently enrolled in any other medical research study which could impact the results of the study
• •History of drug or alcohol abuse within the past year
• •History of allergy or hypersensitivity to MB-102 or iohexol, or other related (iodinated contrast media) products, or any of the inactive ingredients
• •History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
• •Any food allergy, intolerance, restriction or special diet that, in the opinion of the PI, could contraindicate the subject's participation in this study
• •Participants who have allergies to 2 or more classes of drugs. (Intolerance to a drug is not considered a drug allergy)
• •Stable use (no changes within 30 days) of prescription or over the counter (OTC) medications
• •Non-steroidal anti-inflammatory drug (NSAID) use within 2 days of dosing day
• •History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
• •Are homozygous for sickle cell disease
• •Have a known thyroid disorder
• •Have pheochromocytoma
• •Currently on Coumadin (warfarin) who have an International normalized ratio (INR) \>4 at Screening
• •Current history of AIDS or HIV
• •Hepatitis B antigen positive, or C antibody positive
• •Site personnel immediately associated with the study or their immediate family members
• •Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
• •Prior enrollment and dosing in this Pilot 2 study
• •Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin
• •Additional Exclusion: Normal-CKD Stage 2/QuantumLeap
• •History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, pulmonary, hematologic, endocrine, hepatobiliary, nephrologic, immunologic, dermatologic, neurologic (including any history of stroke and/or seizure disorder), psychological, musculoskeletal disease, diagnosis of cancer with the past 2 years or deemed clinically significant or unstable by the Principal Investigator; Note: history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.
• •Additional Exclusion: CKD Stage 3-4/QuantumLeap
• •Stage 5 CKD at the time of screening
• •Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, laparoscopic procedures, or other medical inventions
• •Doses of prednisone greater than 10 mg/day within the last 90 days
• •Main Criteria for Exclusion: (Radiance device)
• •Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
• •o Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
• •Unable to have venous access placed in both arms
• •Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
• •Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
• •History of drug or alcohol abuse within the past year
• •History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
• •History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, MB-102 and iohexol or other related (iodinated contrast media) products (intolerance to a drug is not considered a drug allergy)
• •NSAID use within 2 days of dosing day
• •History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
• •Are homozygous for sickle cell disease
• •Have hyperthyroidism or current thyroid cancer
• •Have pheochromocytoma
• •Currently on Coumadin (warfarin) who have an INR \>4 at Screening
• •Current history of AIDS or HIV
• •Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
• •Site personnel immediately associated with the study or their immediate family members
• •Any characteristics which, in the opinion of the investigator, makes the subject a poor candidate for participation in the clinical trial
• •Prior exposure to MB-102
• •Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin
• •Main Criteria for Exclusion: (Brilliance device)
• •Women who are pregnant, lactating or planning to become pregnant during the study, or women who are of childbearing potential unwilling to use a barrier method of birth control
• •o Males must be unwilling to practice abstinence or utilize adequate contraception from dosing day to at least 7 days post dose
• •Unable to have venous access
• •Recent donation or loss of blood or plasma: 100 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication
• •Participation in another interventional trial within 30 days of dosing or concurrently enrolled in any other medical research study which could impact the results of the study
• •History of drug or alcohol abuse within the past year
• •History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape)
• •History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, or MB-102 (intolerance to a drug is not considered a drug allergy)
• •NSAID use within 2 days of dosing day
• •History of coagulation disorders or bleeding disorders that in the judgement of the investigator places the subject at undue risks for study related procedures
• •Currently on Coumadin (warfarin) who have an INR \>4 at Screening
• •Current history of AIDS or HIV
• •Current evidence of an active Hepatitis B or C infection. If the participant is Hepatitis C antibody positive, but the hepatitis C RNA is below the level of detection, they are considered immune and may be eligible for enrollment.
• •Site personnel immediately associated with the study or their immediate family members
• •Any characteristics which, in the opinion of the investigator, makes the participant a poor candidate for participation in the clinical trial
• •Significant scaring, tattoos or alterations in pigmentation on the sternum that would alter sensor readings versus other areas of the skin
• •Additional Exclusion: Normal-CKD Stage 2/Radiance; Normal-CKD Stage 2/Brilliance algorithm optimization; Normal-CKD Stage 2/Brilliance sensor optimization; Normal-CKD Stage 2/Brilliance sensor validation; and Normal-CKD Stage 2/Brilliance (1-2 sensors)
• •History of significant cardiovascular disease, heart failure, myocardial infarction in the past 3 months, or NYHA class III or IV HF
• •Any other serious or uncontrolled medical disorder, active infection, physical exam finding, laboratory finding, or psychiatric condition that in the opinion of the investigator would limit the participant's ability to complete study requirements or may put the subject at increased risk or compromise interpretability of study results. Note: a history of gallstones or kidney stones are not excluded so long as the condition is not acute within 30 days of dosing.
• •Additional Exclusion: CKD Stage 3-5/Radiance; CKD Stage 3-5/Brilliance algorithm optimization; CKD Stage 3-5/Brilliance sensor validation; and CKD Stage 3-5/Brilliance 1-2 sensors
• •Recent (within 3 months) significant medical condition or surgical procedure including myocardial infarction, thoracic laparoscopic procedures, or other significant medical inventions
• •Received \>20 mg/day of prednisone or an equivalent dose of glucocorticoid for more than 7 days in the last 90 days prior to dosing day for an acute or chronic disorder
• •Currently receiving dialysis
• •Currently anuric