Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers

PHASE1CompletedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 31, 2014

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions
Glomerular Filtration RateAcute Kidney Injury
Interventions
DRUG

Below target dose MP-3180

MP-3180 0.5 µmol/kg (0.186 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

DRUG

At target dose MP-3180

MP-3180 1 µmol/kg (0.186 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

DRUG

2 times above target dose MP-3180

MP-3180 2 µmol/kg (0.744 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

DRUG

4 times above target dose MP-3180

MP-3180 4 µmol/kg (1.488 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

DEVICE

ORFM prototype

The Optical Renal Function Monitor (ORFM) investigational device noninvasively monitors fluorescent light emission from an exogenous tracer agent over time. Prior to administration of MP-3180 and iohexol, ORFM sensor probes were affixed to each of the participants via standard adhesive pads to four locations: forehead, sternum, upper inner arm, side trunk. The administration of the MP-3180 infusion and iohexol infusion occurred at least 15 minutes after the start of the data acquisition software.

OTHER

Iohexol comparator

Iohexol (Omnipaque 300, 5 mL) (comparator agent) was administered by IV injection over 2 minutes after MP-3180 injection, followed by a 10 mL saline flush IV over 2 minutes.

Trial Locations (1)

21201

University of Maryland, Baltimore

Sponsors

Lead Sponsor

All Listed Sponsors
lead

MediBeacon

INDUSTRY