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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01141179
First received: June 9, 2010
Last updated: November 1, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Renal Impairment
Drug: LEO 27847
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847

Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • PK parameters [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    (AUC, Cmax)in each group of renal impairment


Secondary Outcome Measures:
  • PD parameters [ Time Frame: 1 week ] [ Designated as safety issue: Yes ]
    (Calcium, phosphate, PTH), Vitamin D in each group of renal impairment


Enrollment: 25
Study Start Date: May 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LEO 27847 Drug: LEO 27847
2 mL (0.1 mg) dose of oral solution

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01141179

Locations
Canada, Ontario
Anapharm
Toronto, Ontario, Canada, M2P 1N6
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Richard Larouche, MD Anapharm
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01141179     History of Changes
Other Study ID Numbers: LEO 27847-S03
Study First Received: June 9, 2010
Last Updated: November 1, 2013
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on August 27, 2014