| Eligibility |
Inclusion criteria for all subjects:
1. Age from 18 to 79 years, inclusive, at the time of signing of the ICF.
2. Body weight =50 kg and BMI 19 to 40 kg/m2, inclusive.
3. Systolic blood pressure =170 mmHg and diastolic blood pressure =100 mmHg at Screening
and Day 1.
4. No clinically significant abnormalities on physical examination at Screening.
5. Alanine aminotransferase and aspartate aminotransferase up to 1.5 x the upper limit of
normal (ULN) as long as total bilirubin and alkaline phosphatase are = ULN.
6. No clinically significant abnormalities on ECG and QTcF <480 msec at Screening.
7. Female subjects are not pregnant, non-lactating, and must be of non-childbearing
potential being either surgically sterile (eg, documented hysterectomy, bilateral
oophorectomy, bilateral salpingo oopherectomy, tubal ligation) or post-menopausal
women (over 45 years of age with 12 months or more amenorrhea verified by follicle
stimulating hormone assessment and the absence of other biological or physiological
causes).
8. Male subjects who are sexually abstinent or surgically sterilized (vasectomy), or
those who are sexually active with a female partner(s) and agree to use an acceptable
method of contraception (such as condom with spermicide) combined with an acceptable
method of contraception for their non-pregnant female partner(s) after informed
consent, throughout the study, and for a minimum of 90 days after the last dose, and
who do not intend to donate sperm in the period from Screening until 3 months
following administration of the study drug.
9. Subject using medications known to affect the elimination of serum creatinine (eg,
cimetidine, trimethoprim) within the past 30 days.
10. Capable of providing informed consent and willing to comply with the requirements of
the protocol.
Specific inclusion criteria for subjects with NORMAL renal function:
11. Estimated GFR (based on MDRD equation) =90 mL/min/1.73 m2 (normal) as determined by an
average of 2 values obtained at least 48 hours apart within the previous 3 months.
12. White blood cell (WBC) count, hemoglobin and platelet count within normal limits.
Absolute neutrophil count of >1500/µL for African Americans and >2000/µL for other
races.
Specific inclusion criteria for subjects with RENAL IMPAIRMENT:
13. Estimated GFR <90 mL/min/1.73 m2 (based on MDRD equation) as determined by an average
of 2 values obtained at least 48 hours apart and within the previous 3 months.
14. Stable renal function as determined by <20% difference in serum creatinine obtained on
2 occasions at least 48 hours apart and within the previous 3 months.
15. Platelet count =100,000/mm3, hemoglobin count =10g/dL, WBC count within normal limits.
Absolute neutrophil count of >1500/µL for African Americans and >2000/µL for other
races.
Exclusion criteria for all subjects:
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.
Specific exclusion criteria for subjects with NORMAL renal function:
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).
Specific exclusion criteria for subjects with RENAL IMPAIRMENT:
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.
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