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

NCT ID: NCT01141179

Last Updated: 2025-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2011-02-28

Brief 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.

Conditions

Renal Impairment

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LEO 27847

Group Type: EXPERIMENTAL

LEO 27847

Intervention Type: DRUG

2 mL (0.1 mg) dose of oral solution

Interventions

LEO 27847

2 mL (0.1 mg) dose of oral solution

Intervention Type: DRUG

Eligibility Criteria

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).

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LEO Pharma

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard Larouche, MD

Role: PRINCIPAL_INVESTIGATOR

Anapharm

Locations

Anapharm

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

LEO 27847-S03

Identifier Type: -

Identifier Source: org_study_id