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

LEO Pharma

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: LEO 27847

Study type: Interventional

Funder types: Industry

Identifiers

NCT01141179

LEO 27847-S03

Details and patient eligibility

About

The study will investigate the impact of reduced renal function on the pharmacokinetic and pharmacodynamic profile of LEO 27847. Volunteers with different degrees of renal impairment will be administered one dose of the investigational drug and then followed until investigational drug is eliminated from the body.

Enrollment: 25 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

25 participants in 1 patient group

LEO 27847

Experimental group

Treatment:

Drug: LEO 27847