Clinical trial NCT02098187: Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers
Official title: Pilot 1B Study-Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Glomerular Filtration Rate
Acute Kidney Injury
Keywords: Glomerular Filtration Rate
Acute Kidney Injury
Lead sponsor: MediBeacon
Sponsor class: INDUSTRY
First posted: 2014-03-27
Enrollment: 16
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this early feasibility study was to investigate the pharmacokinetics of MP-3180 administered in rising doses and to evaluate the use of the Optical Renal Function Monitor (ORFM), an investigational noninvasive fluorescence detection device.

Detailed description: This was an open-label, rising single-dose study to investigate the pharmacokinetics of the investigational agent, MP-3180, and to evaluate the use of the Optical Renal Function Monitor (ORFM), an investigational noninvasive fluorescence detection device. Single-dose pharmacokinetics at four dose levels were evaluated following the administration of a single, intravenous dose of MP-3180. Iohexol was also administered followed by saline. Prior to administration of MP-3180 and iohexol, ORFM sensor probes were affixed to four locations on the body of each participant. The noninvasive fluorescent signal from MP-3180 was measured using the ORFM investigational device continuously for approximately four hours post MP-3180 administration. For the determination of the pharmacokinetic disposition of MP-3180 and iohexol, blood samples were collected from each participant provided the individual completed all blood collections in the study. The pharmacokinetics of MP-3180 and iohexol were assessed by statistical comparison of pharmacokinetic parameters derived from plasma concentration-time curves and urine recovery data.

Eligibility criteria: Inclusion Criteria:

1. Age: 22 years of age or older
2. Sex: Males and not of childbearing potential females
3. Capable of informed consent
4. Weight restrictions:

   1. at least 50 kg (110 lbs) for men
   2. at least 48 kg (106 lbs) for women
   3. all participants will have a Body Mass Index (BMI) less than or equal to 33 but greater than or equal to 19
5. All participants should be judged by the Principal Investigator or Medical Sub-Investigator physician as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication

Exclusion Criteria:

1. Institutionalized participants will not be used
2. History of any significant cardiovascular disease, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
3. Donation or loss of blood or plasma: 50 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.
4. Intolerance to venipuncture.
5. Participants who have received an investigational drug within 30 days prior to the initial dose of study medication.
6. History of drug and/or alcohol abuse within the past year, unless currently enrolled in an abstinence program.
7. History of allergy or hypersensitivity to MP-3180 or iohexol, or other related products, or any of the inactive ingredients.
8. History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape).
9. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the participant's participation in this study.
10. History of allergy or hypersensitivity to iodine containing contrast media or drugs.
11. Acute illness at the time of either the pre-study medical evaluation or dosing.
12. Social Habits:

    1. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
    2. Ingestion of any vitamins or herbal supplement within 7 days prior to the initial dose of study medication.
    3. Any significant change in dietary or exercise habits within the 48 hours prior to the initial dose of study medication.
13. Medications:

    a. Use of any prescription or over-the-counter (OTC) medications within the 7 days prior to the initial dose of study medication.
14. Not within normal limits or clinically significant for lab testing; serum chemistries, hematology, urinalysis.

Primary outcomes:
measure: Total plasma clearance of MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
measure: Renal clearance of MP-3180 and iohexol
timeFrame: 60, 120, 240, 360, 600 and 720 minutes post-dose
measure: Maximum Plasma Concentration (Cmax) for MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
measure: Time to Maximum Plasma Concentration (Tmax) for MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
measure: The terminal rate constant for MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
measure: Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration for MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
measure: Area under the plasma concentration-time curve from time zero to infinity for MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
measure: The elimination half-life of MP-3180 and iohexol
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 1, 3, and 8 hours after dosing, and within 2 weeks after the final study dose
measure: Number of laboratory values that fall outside of pre-specified normal ranges
timeFrame: Pre-dose and within 2 weeks after the final study dose
Other outcomes:
measure: Correlation between MP-3180 fluorescence intensity and MP-3180 concentration in plasma
timeFrame: Pre-dose and 5, 10, 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 480 and 720 minutes post-dose
Locations:
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
Study officials:
affiliation: MediBeacon, LLC
name: Richard B. Dorshow, Ph.D.
role: STUDY_DIRECTOR
References: