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

Renal Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01141179
• Other study ID #: LEO 27847-S03
• Status: Completed
• Phase: Phase 1
• First received: June 9, 2010
• Last updated: November 1, 2013
• Start date: May 2010
• Est. completion date: February 2011

Study information

• Verified date: November 2013
• Source: LEO Pharma
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Impairment
• Renal Insufficiency

Intervention

Drug:
• LEO 27847
2 mL (0.1 mg) dose of oral solution

Locations

Country	Name	City	State
Canada	Anapharm	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
LEO Pharma

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK parameters	(AUC, Cmax)in each group of renal impairment	1 week	No
Secondary	PD parameters	(Calcium, phosphate, PTH), Vitamin D in each group of renal impairment	1 week	Yes