NCT03095391

The Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™

A Phase 2b Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of FAST PV and mGFR Technology™ in Healthy Subjects and Patients With Varying Degrees of Renal Impairment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 32 (actual)
• Sponsor: FAST BioMedical · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 2b, prospective, open-label study designed to evaluate the safety, tolerability, PK, and PD of FAST PV and mGFR Technology in healthy subjects and patients with varying degrees of renal impairment.

Detailed description

For Cohorts 1 and 2, administration of the study drug will occur within 21 days of screening. Eligible subjects/patients will be admitted to the clinical research unit (CRU) on Day -1, at which time assessments will be performed, and results from both screening and Day -1 (inclusion/exclusion criteria, body weight, height \[screening only\], body mass index \[BMI\], medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical laboratory tests, renal function assessment, follicle-stimulating hormone \[FSH; screening only\] and pregnancy test \[females only\], and urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility. For Cohorts 3 and 4, administration of the study drug will occur within 21 days of screening. Eligible subjects/patients will be admitted to the CRU on Day 1, at which time assessments will be performed and results from both screening and predose administration testing (inclusion/exclusion criteria, body weight, height \[screening only\], BMI, medical and surgical history, physical examination, vital signs and pulse oximetry, 12 lead ECG, clinical laboratory tests, renal function assessment, FSH and pregnancy test \[screening only\], and urine drugs of abuse and alcohol screen) will be reviewed to confirm eligibility. Cohort 1: Eligible subjects will receive a single dose of VFI followed 130 minutes later by a 350 mL infusion of 5% albumin up to maximum volume of 7 mL/kg over 30 minutes on Day 1. Subjects will remain resident in the CRU for at least 24 hours after VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU for an end-of-study (EOS) visit on Day 21 (± 1 day). Cohort 2: Eligible subjects will receive a dose of VFI followed 160 minutes later by a single dose of Iohexol on Day 1 and a second dose of VFI 24 hours following the initial dose of VFI. Subjects will remain resident in the CRU for at least 24 hours after the second VFI administration for safety, PK, and PD assessments. Subjects will return to the CRU for follow-up visits on Days 5 (± 1 day), 9 (± 1 day), and 16 (± 1 day) and an EOS visit on Day 22 (± 1 day). Cohorts 3 and 4: Eligible patients will receive a single dose of VFI followed 160 minutes later by a single dose of Iohexol on Day 1. Patients will remain in the CRU through the 12-hour sample collection after VFI administration for safety, PK, and PD assessments. . Patients will stay at a local hotel near the CRU and will return to the CRU on Day 2 for the 24-hour sample collection. Patients will return to the CRU for follow-up visits on Days 4 (± 1 day), 8 (± 1 day), and 15 (± 1 day) and an EOS visit on Day 21 (± 1 day).

Conditions

• Kidney Diseases
• Renal Insufficiency, Chronic
• Acute Kidney Injury
• Urologic Diseases
• Renal Insufficiency

Interventions

Type	Name	Description
DEVICE	VFI	The IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
DEVICE	Iohexol	Iohexol is a contrast enhancement agent which, following intravascular injection, is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration.

Timeline

• Start date: 2017-06-13
• Primary completion: 2017-09-20
• Completion: 2017-09-20
• First posted: 2017-03-29
• Last updated: 2018-12-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study