Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
- Conditions
- Renal InsufficiencyHealthy
- Interventions
- Biological: MGTA-145
- Registration Number
- NCT04154670
- Lead Sponsor
- Ensoma
- Brief Summary
This study is being conducted in healthy subjects and in subjects with a mild or moderate decrease in GFR (subjects with renal impairment).
- Detailed Description
To investigate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Normal kidney function MGTA-145 MGTA-145 single dose Moderate decrease in GFR MGTA-145 MGTA-145 single dose Mild decrease in GFR MGTA-145 MGTA-145 single dose
- Primary Outcome Measures
Name Time Method Pharmacokinetics Biomarkers 2 days Investigate renal clearance of MGTA-145
- Secondary Outcome Measures
Name Time Method Safety and Tolerability 15 days Investigate the safety and tolerability of MGTA-145 following intravenous (IV) administration as monotherapy in subjects with varying degrees of renal impairment (e.g. adverse events, clinical laboratory tests, vital signs, ECGs)
Trial Locations
- Locations (2)
Alliance for Multispeciality Research (AMR) Formerly New Orleans Center for Clinical Research (NOCCR)
🇺🇸Knoxville, Tennessee, United States
Orlando Clinical Research Center (OCRC)
🇺🇸Orlando, Florida, United States