NCT01491113

Pharmacokinetic (PK) Study in Japanese Non-epileptic Renal Impaired Patients

Single-Dose Pharmacokinetics of Orally Administered Levetiracetam (LEV) in Japanese Subjects With Normal Renal Function and Various Degrees of Renal Impairment Using a Dosing Regimen Adjusted to Renal Function (250 mg or 500 mg)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: UCB Pharma · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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 with various degrees of impaired renal function.

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 subjects with normal renal function and in Japanese subjects with various degrees of renal impairment.

Conditions

• Healthy Subjects
• Renal Impairments

Interventions

Type	Name	Description
DRUG	Levetiracetam 250 mg	Tablet containing Levetiracetam 250 mg
DRUG	Levetiracetam 500 mg	Tablet containing Levetiracetam 500 mg

Timeline

• Start date: 2011-11-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2011-12-13
• Last updated: 2014-02-10
• Results posted: 2014-01-10

Locations

2 sites across 1 country: Japan