Pilot PK/PD Study of DS-1093a in Patients With Chronic Kidney Disease

Exclusion Criteria

• •Use of ESAs within 2 weeks prior to dosing.
• •Uncontrolled hypertension despite optimal medical therapy, defined as \> 160/100 mmHg after 10 minutes of rest at screening, and \> 180/110 mmHg after 10 minutes of rest on Day -1 pre-dose.
• •Known haemoglobinopathy.
• •Acute renal failure (as judged by the Investigator).
• •History of kidney transplant regardless of functionality.
• •Start of any new medication or any changes to a current dosage within 7 days prior to study drug administration.
• •Chronic liver disease.
• •Positive hepatitis B surface antigen (HBsAg) or hepatitis C virus (HCV) antibody test.
• •Positive test for human immunodeficiency virus (HIV)-1 or HIV-2.
• •A history of gastrointestinal bleeding.
• •History of a thrombotic event (e.g., myocardial infarction, stroke or transient ischemic attack, peripheral embolism, venous thromboembolism, etc.)
• •Patients with poorly controlled diabetes despite optimal medical therapy.
• •A history of cancer, except basal cell skin cancer, squamous cell skin cancer, or cervical cancer (if judged by the Investigator to be in full remission).
• •Hypersensitivity to any components of the study drug.
• •Requirement for any concomitant medication that cannot be withheld on Day 1 until 4 hours post-dose (insulin is allowed to cover the breakfast, if necessary).
• •Clinically relevant abnormal medical history, physical findings, ECG, or laboratory values at the screening assessments that could interfere with the objectives of the trial or the safety of the patient.
• •Participation in another investigational drug trial within 30 days prior to dosing (or 5 times the half-life of the drug, whichever is longer) or exposure to more than three new investigational agents within 12 months prior to enrolment.
• •Abuse of drugs or alcohol during the 2 years before the first dose of trial medication.
• •Ingestion of alcohol within 72 hours prior to dosing and during confinement. Outside the in-house period, regular alcohol consumption must not exceed 16 units for males and 7 units for females per week (1 unit equals 340 mL of beer, 115 mL of wine or 43 mL of spirits).
• •Positive drug screen (if not due to concomitant medication) or alcohol breath test at screening and/or Day -1.
• •Patients who smoke more than 10 cigarettes per day (or equivalent), and who would not be able to abstain from smoking during the in-house period.
• •Concomitant use of medications known to affect the elimination of serum creatinine (e.g., trimethoprim or cimetidine) and competitors of renal tubular secretion (e.g., probenecid) within 30 days before dosing.
• •Use of a strong inducer or inhibitor of CYP enzymes, during the 30 days before dosing.
• •Use of any other prohibited medication.
• •Loss of more than 400 mL blood, or donation of blood, plasma, platelets, or any other blood components, during the 3 months before the trial, or unwilling to abstain from donating during the study and for 3 months after receipt of the final dose of trial medication.
• •Possibility that the patient will not cooperate with the requirements of the protocol