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

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ClinicalTrials.gov Identifier: NCT01141179
Recruitment Status : Completed
First Posted : June 10, 2010
Last Update Posted : November 4, 2013
Information provided by (Responsible Party):
LEO Pharma

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.

Condition or disease Intervention/treatment Phase
Renal Impairment Drug: LEO 27847 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847
Study Start Date : May 2010
Primary Completion Date : February 2011
Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: LEO 27847 Drug: LEO 27847
2 mL (0.1 mg) dose of oral solution

Primary Outcome Measures :
  1. PK parameters [ Time Frame: 1 week ]
    (AUC, Cmax)in each group of renal impairment

Secondary Outcome Measures :
  1. PD parameters [ Time Frame: 1 week ]
    (Calcium, phosphate, PTH), Vitamin D in each group of renal impairment

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141179

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

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01141179     History of Changes
Other Study ID Numbers: LEO 27847-S03
First Posted: June 10, 2010    Key Record Dates
Last Update Posted: November 4, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases