Safety and Pharmacokinetics of AT1001 (Migalastat HCl) in Healthy Subjects and Subjects With Impaired Renal Function

Inclusion Criteria

• •males or females aged 18 to 70 years inclusive (subjects with normal renal function, mild or moderate renal impairment), and 18 to 75 years inclusive (subjects with severe renal impairment)
• •body mass index 18.0 to 40.0 kilogram (kg)/square meter (m\^2) inclusive
• •females who are non-pregnant, non-lactating, or postmenopausal for \>=1 year, surgically sterile for \>= 90 days, or agree to use approved methods of contraception
• •males will be sterile or use approved methods of contraception
• •understands and signs informed consent form Healthy subjects with normal renal function
• •negative test for selected drugs of abuse (excludes alcohol) at Screening and Check-in
• •good health with no clinically significant medical history, physical examination, vital signs, or 12-lead ECG
• •clinical laboratory tests within the reference range or not clinically significant
• •normal renal function (estimated CLcr \>90 mL/min) at Screening Subjects with mild, moderate or severe renal impairment
• •negative test for selected drugs of abuse (excludes alcohol) at Screening and Check-in or verification of a prescription for a positive test
• •renal impairment (estimated CLcr \<90 mL/min)
• •evidence of stable renal impairment defined as two separate estimated CLcr values within 25%
• •clinical laboratory results consistent with their renal condition or of no clinical significance for the study
• •abnormal laboratory values must not be clinically significant. Anemia secondary to renal disease is acceptable if hemoglobin is ≥9 g/dL and no clinically significant symptoms. Liver enzymes and bilirubin must be below twice the upper normal level
• •subjects with renal impairment must have stable underlying medical conditions \< 90 days before study start
• •stable medication regimen(s) (no new drug(s) or changed dosage(s) \<30 days before study drug)
• •in good general health, allowing for concurrent illnesses associated with chronic kidney disease