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

Information source: UCB Pharma
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy Subjects; Renal Impairments

Intervention: Levetiracetam 250 mg (Drug); Levetiracetam 500 mg (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: UCB Pharma

Official(s) and/or principal investigator(s):
UCB Clinical Trial Call Center, Study Director, Affiliation: +1 877 822 9493 (UCB)

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.

Clinical Details

Official title: 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)

Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D

Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to the Last Quantifiable Concentration for Groups A to D

Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D

Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D

Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period

Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E

Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period

Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E

Secondary outcome:

Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D

Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D

Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D

Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D

Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D

Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D

Renal Clearance (CLR) of Ucb L057 for Groups A to D

Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period

Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D

Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D

Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D

Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D

Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D

Terminal Half-life (t1/2) of Ucb L057 for Groups A to D

Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period

Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E

Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period

Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period

Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E

Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E

Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E

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.

Eligibility

Minimum age: 20 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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 Criteria:

- Subjects has taken any drug treatment, disease or injury to influence Levetiracetam

PK except for renal impairments

Locations and Contacts

1, Fukuoka, Japan

2, Ibaraki, Japan

Additional Information

Product information

FDA Safety Alerts and Recalls

Starting date: November 2011
Last updated: January 13, 2014

Page last updated: August 23, 2015

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