Study of Pharmacokinetics of a Single IV Dose of CB-238,618 in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Subjects

Inclusion Criteria:

- Subjects with renal impairment are to have mild, moderate, or severe renal impairment,
or ESRD requiring HD. ESRD subjects requiring HD should have been receiving HD on a
three times/week schedule for at least three months preceding the initial dose in this
study

Exclusion Criteria:

- For healthy subjects (Group A): history or presence of any clinically significant
illness (e.g., cardiovascular, pulmonary, hepatic, renal, hematologic,
gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic,
musculoskeletal, or psychiatric) or any other condition, including clinically
significant anemia, which in the opinion of the investigator would jeopardize the
safety of the subject or the validity of the study results

- For renally impaired subjects (Groups B to E): as above, except that renal
insufficiency and other medical conditions commonly associated with renal impairment
(eg, hypertension, diabetes, which should be stable for at least three months
preceding the initial dose of study medication in this study) are allowed

- Clinically significant abnormalities on physical examination, medical history, 12-lead
electrocardiogram (ECG), vital signs, or laboratory values, as judged by the
investigator or designee. Subjects with renal impairment should have clinical
laboratory values consistent with their disease and approved by the investigator

- Evidence of clinically significant hepatic impairment including alanine
aminotransferase or aspartate aminotransferase > 1.5 × upper limit of normal (ULN) or
bilirubin > 1 × ULN

- Hemoglobin <8 g/dL, unless considered stable and not clinically significant in the
opinion of the investigator in subjects with ESRD and on HD;

- Subjects with renal impairment who are not on a chronic stable drug regimen, defined
as starting a new drug or changing dosage within 14 days prior to administration of
study medication, except for drugs administered in relationship to HD

- Subjects with fluctuating or rapidly deteriorating renal function. Assessment of the
stability of the subject's renal function will be determined by the investigator

- Subject has a currently functioning renal transplant and/or has been on significant
immunosuppressant therapy, as determined by the investigator, within the last six
months