Study Assessing PK and Safety of MGTA-145 in Subjects With Normal Estimated GFR and Varying Degrees of Renal Impairment

Exclusion Criteria

• •1. Clinically significant abnormal finding on physical examination conducted at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
• •2. History of chronic alcohol or drug abuse within the previous 12 months. Subject has a positive pre-study drug/alcohol screen (to include at minimum: amphetamines, barbiturates, cocaine, opiates, cannabinoids, benzodiazepines, and myelosuppressive drugs). A subject with a positive finding on the drug screen may still be enrolled at the discretion of the Investigator if a plausible clinical explanation exists (eg, prior or concomitant medication use).
• •3. History of kidney transplantation or requiring dialysis or anticipated to initiate dialysis during the study period.
• •4. Donation of more than 500 mL of blood or plasma within 12 weeks prior to dosing.
• •5. Subject smokes more than 10 cigarettes per day (or equivalent) or has done so within 6 months prior to the Screening Visit.
• •6. Acute illness, infection (requiring medical treatment \[eg, antibiotics\]), or surgery within 30 days of dosing.
• •7. Seropositive for hepatitis B surface antigen, hepatitis C virus antibody, or human immunodeficiency virus.
• •8. Subject has received another investigational drug or participated in an investigational device study within 30 days prior to dosing.
• •9. History of anaphylaxis or clinically important reaction to any drug including plerixafor.
• •10. Any clinically significant laboratory value outside the normal range at Screening. The assessment may be repeated once prior to treatment number assignment. If the repeat value(s) remains outside of protocol-specified ranges, the subject will be excluded from the study. Note: Re assessment is not allowed for subjects who have a positive urine drug screen test at Screening.
• •11. Any clinically significant hematologic, cardiovascular, pulmonary, central nervous system, metabolic, hepatic, or gastrointestinal conditions or history of conditions that, in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this study or may interfere with the interpretation of the study results.
• •12. Subject has used any prescription drugs within 14 days prior to dosing or any dietary supplements or non prescription drugs within 7 days prior to dosing unless deemed acceptable by the Investigator and Sponsor (Magenta Medical Monitor).
• •13. Presence of acute kidney injury.
• •14. Clinically significant laboratory abnormalities excluding those associated with renal impairment or the underlying cause of renal disease.
• •15. Unstable medical condition or underlying medical condition that has changed within the past 90 days.
• •16. Presence of laboratory abnormalities or clinically significant medical condition that in the opinion of the Investigator may place the subject at an unacceptable risk as a participant in this study or may interfere with the interpretation of the study results.
• •17. Changes in prescription medications within 14 days prior to dosing or anticipated changes during the study period.