Pharmacokinetics of MP-3180 in Healthy Volunteers
NCT02098174 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2016-09-23
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.
Conditions
- Glomerular Filtration Rate
- Acute Kidney Injury
Interventions
- DRUG
-
MP-3180
MP-3180 (1 µmol/kg or 0.372 mg/kg) (fluorescent tracer agent) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
- OTHER
-
Iohexol comparator
Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
Sponsors & Collaborators
-
MediBeacon
lead INDUSTRY
Principal Investigators
-
Thomas Dowling, Ph.D. · University of Maryland
-
Richard B. Dorshow, Ph.D. · MediBeacon, LLC
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2013-11-30
- Primary Completion
- 2014-01-31
- Completion
- 2014-01-31
Countries
- United States
Study Locations
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