Status:
COMPLETED
Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients
Lead Sponsor:
UCB Pharma
Collaborating Sponsors:
Parexel
Conditions:
Healthy Subjects
Renal Impairments
Eligibility:
All Genders
20-80 years
Phase:
PHASE4
Brief Summary
This is a human pharmacology, single-dose study to investigate the pharmacokinetics of orally administered Levetiracetam (LEV) in Japanese subjects with normal renal function and in Japanese subjects ...
Detailed Description
The primary objective of this study is to evaluate the plasma and urine PK of Levetiracetam (ucb L059) and its metabolite (ucb L057) after a single dose of LEV 250 mg or LEV 500 mg in Japanese subject...
Eligibility Criteria
Inclusion
- Healthy subjects with normal renal function
- Subject is Japanese
- Subjects with creatinine clearance within 1 of 3 Groups (CLcr\[mL/min/1.73 cm\^2\]: Group B: 50 - \<80, Group C: 30 - \<50, Group D: \<30), or for Group E, subjects with end-stage renal failure undergoing hemodialysis
Exclusion
- Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01491113
Start Date
November 1 2011
End Date
November 1 2012
Last Update
February 10 2014
Active Locations (2)
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1
1
Fukuoka, Japan
2
2
Ibaraki, Japan