NCT02098187

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

Pilot 1B Study-Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: MediBeacon · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Accepted

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.

Conditions

• Glomerular Filtration Rate
• Acute Kidney Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-03-01
• Completion: 2014-03-01
• First posted: 2014-03-27
• Last updated: 2016-09-26

Locations

1 site across 1 country: United States