Clinical trial NCT02098174: Pharmacokinetics of MP-3180 in Healthy Volunteers
Official title: Pharmacokinetics of MP-3180 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: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg) compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in healthy adult participants. The secondary objective was to evaluate the safety and tolerability of MP-3180 in healthy adult participants.

Detailed description: Single-dose pharmacokinetics were characterized in sixteen (16) healthy, adult male participants in this Phase 1, open-label study following the administration of a single, intravenous 1 µmol/kg dose over 2 minutes followed by 10 mL saline under fasting conditions. Iohexol (Omnipaque-300, 5 mL of a 300 mg I/mL solution) was also administered over 2 minutes followed by 10 mL of saline. The pharmacokinetics of MP-3180 and iohexol was 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:

  * a. at least 50 kg (110 lbs) for men
  * b. at least 48 kg (106 lbs) for women
  * c. 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. Social habits:

  * a. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
  * b. Ingestion of any vitamins or herbal supplement within 7 day prior to the initial dose of study medication.
  * c. Any significant change in dietary or exercise habits within the 48 hours prior to the initial dose of study medication.
  * d. History of drug and/or alcohol abuse within the past year, unless currently enrolled in an abstinence program.
* 3. Use of any prescription or over-the-counter (OTC) medications within the 7 days prior to the initial dose of study medication.
* 4. 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.
* 5. Acute illness at the time of either the pre-study medical evaluation or dosing.
* 6. Not within normal limits or clinically significant for lab testing
* 7. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the participant from safely participating in the study.
* 8. 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.
* 9. Intolerance to venipuncture.
* 10. Participants who have received an investigational drug within 30 days prior to the initial dose of study medication.
* 11. History of allergy or hypersensitivity to MP-3180 or iohexol, or other related products, or any of the inactive ingredients.
* 12. 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.
* 13. History of allergy or hypersensitivity to iodine containing contrast media or drugs.

Primary outcomes:
measure: Total plasma clearance of MP-3180 and iohexol
timeFrame: Pre-dose and the following times after dosing: 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: Pre-dose and each time the participant voided up to 720 minutes post dose
measure: Maximum Plasma Concentration (Cmax) for MP-3180 and iohexol
timeFrame: Pre-dose and the following times after dosing: 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 the following times after dosing: 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 the following times after dosing: 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 the following times after dosing: 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 the following times after dosing: 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 the following times after dosing: 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 the plasma clearance of MP-3180 and the plasma clearance of iohexol
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: University of Maryland
name: Thomas Dowling, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: MediBeacon, LLC
name: Richard B. Dorshow, Ph.D.
role: STUDY_DIRECTOR
References: