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

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.

Study Overview

• Status: Completed
• Conditions: Renal Impairment
• Intervention / Treatment: Drug: LEO 27847

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 1

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M2P 1N6
      • Anapharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LEO 27847	Drug: LEO 27847; 2 mL (0.1 mg) dose of oral solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK parameters	(AUC, Cmax)in each group of renal impairment	1 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PD parameters	(Calcium, phosphate, PTH), Vitamin D in each group of renal impairment	1 week

Collaborators and Investigators

• Sponsor: LEO Pharma
• Investigators: Principal Investigator: Richard Larouche, MD, Anapharm

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (Actual): February 1, 2011
• Study Completion (Actual): February 1, 2011

Study Registration Dates

• First Submitted: June 9, 2010
• First Submitted That Met QC Criteria: June 9, 2010
• First Posted (Estimate): June 10, 2010

Study Record Updates

• Last Update Posted (Estimate): November 3, 2013
• Last Update Submitted That Met QC Criteria: November 1, 2013
• Last Verified: November 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency
• Other Study ID Numbers: LEO 27847-S03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No