Status:
COMPLETED
The Impact of Renal Impairment on the Pharmacokinetic and Pharmacodynamic of LEO 27847
Lead Sponsor:
LEO Pharma
Conditions:
Renal Impairment
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 administe...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01141179
Start Date
May 1 2010
End Date
February 1 2011
Last Update
February 24 2025
Active Locations (1)
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1
Anapharm
Toronto, Ontario, Canada, M2P 1N6