The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847

This is an interventional treatment trial for Renal Impairment Read More

Main Inclusion Criteria:

• Male and/or non-childbearing potential female, 18 years of age and older, healthy or with stable renal impairment (deemed stable by the referring physician for at least the last 4 weeks and not expected to change significantly during the next 3 months)
• BMI ≥18.0 and ≤ 42 kg/m2
• Patients with stable concomitant medical conditions

• Healthy subjects or patients with a creatinine clearance (at the time of screening) estimated using the formula of Cockcroft and Gault within the range of:

  • ≥ 50 to ≤ 80 mL/min (Mild Group: 8 subjects),
  • ≥ 30 to < 50 mL/min (Moderate Group: 8 subjects),
  • < 30 mL/min (Severe Group: 8 subjects).

Main Exclusion Criteria:

• Patients with renal transplants or currently on haemodialysis or peritoneal dialysis
• Clinically significant illness or surgery within 4 weeks prior to dosing
• Clinically significant ECG abnormalities or vital sign abnormalities at screening
• History of stroke, cerebrovascular disorder, coronary angioplasty and coronary bypass graft
• Clinically significant history or presence of any gastrointestinal pathology

• Use of medications other than their stable medications within 14 days prior to administration of investigational product or over-the-counter products within 7 days prior to administration of investigational product, except for:

  • multivitamins or vitamin D taken on a regular basis
  • topical products without systemic absorption
• Hemoglobin ≤ 90 g/L
• Serum total calcium (adjusted for albumin) level < 2.25 mmol/L
• Clinically significant history of congestive heart failure, cardiac dysfunction or liver disease