Ignite Creation Date:
2024-05-06 @ 8:35 AM
Last Modification Date:
2024-10-26 @ 12:02 PM
Study NCT ID:
NCT02772276
Status:
COMPLETED
Last Update Posted:
2023-10-26
First Post:
2016-05-10
Brief Title:
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
Sponsor:
MediBeacon
Organization:
MediBeacon
Study Overview
Official Title:
A Pilot Safety and Pharmacokinetic Study of MB-102 Versus Iohexol and the 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
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study was a pilot safety and pharmacokinetic study of MB-102 versus iohexol and the use of the non-invasive optical renal function monitor ORFM device in normal and compromised renal function participants with different skin color types
Detailed Description:
The objectives of this study were to evaluate the safety and tolerability of single and multiple doses of MB-102 in participants with normal and impaired kidney function to determine plasma pharmacokinetics of MB-102 compared to the pharmacokinetics of iohexol in participants with normal and impaired kidney function to demonstrate that MB-102-transdermal-fluorescence-measured glomerular filtration rate GFR using the optical renal function monitor ORFM Brilliance device is aligned with MB-102 plasma GFR to evaluate the safety and effectiveness of the ORFM investigational medical device prototypes QuantumLeap Radiance and Brilliance for the non-invasive transdermal fluorescent detection of MB-102 in participants with a range of skin color types and to determine the optimal dose of MB-102 for non-invasive measurement
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None