NCT02772276 - Pharmacokinetics of MB-102 and Use of the Non-invasive Optical Renal Function Monitor (ORFM) Device in Subjects With Normal and Impaired Renal Function and a Range of Skin Color Types | Biotech Hunter

Enrollment

234

Participants

Timeline

Start Date

May 11, 2016

Primary Completion Date

August 4, 2021

Study Completion Date

August 4, 2021

Conditions

Acute Kidney Injury

Interventions

DRUG

MB-102-- single dose of 4 µmol/kg

4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

DRUG

MB-102-- single dose of 130 mg

130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.

DRUG

MB-102-single dose of 130 mg or 2 doses of 130 mg 12 hours apart

130 mg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.

DRUG

MB-102-- two doses of 130 mg 24 hours apart

4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.

DRUG

Iohexol

5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds

DEVICE

QuantumLeap

Optical Renal Function Monitor (ORFM)

DEVICE

Radiance

Optical Renal Function Monitor (ORFM)

DEVICE

Brilliance (1 or 2 sensors)

Optical Renal Function Monitor (ORFM)

DEVICE

Brilliance (2-part sensor)

Optical Renal Function Monitor (ORFM)

Trial Locations (3)

32132

Riverside Clinical Research, Edgewater

32809

Orlando Clinical Research Center, Orlando

63110

Washington University School of Medicine, St Louis