Healthy SubjectsPhase 4NCT01491113

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

A Phase 4 study testing Levetiracetam 250 mg and Levetiracetam 500 mg in people with Healthy Subjects and Renal Impairments, run by UCB Pharma at 2 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 20 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects, Renal Impairments
What is being tested?: Levetiracetam 250 mg and Levetiracetam 500 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 2 sitesJapan
Study dates: Nov 2011to Nov 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 to 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments

Trial locations and contacts

2 sites in 1 country.

Japan2 sites

1
Fukuoka
2
Ibaraki

Other trials in Japan

About this study

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)

Read the 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
Being tested: Levetiracetam 250 mg, Levetiracetam 500 mg
Keywords: Levetiracetam, Oral administration, Japanese, Non-epileptic, Healthy, Renal impaired subjects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Levetiracetam 250 mgDrug
Also called E-Keppra
Tablet containing Levetiracetam 250 mg
Levetiracetam 500 mgDrug
Also called E-Keppra
Tablet containing Levetiracetam 500 mg

Study groups in NCT01491113
Study group	Role	What they receive
Group A: Normal renal function	Experimental	Subjects who have normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be taken through to Day 4 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose Receives: Drug: Levetiracetam 500 mg
Group B: Mild renal impairment	Experimental	Patients who have mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects will be orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 5 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose Receives: Drug: Levetiracetam 500 mg
Group C: Moderate renal impairment	Experimental	Patients who have moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 6 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose Receives: Drug: Levetiracetam 250 mg
Group D: Severe renal impairment	Experimental	Patients who have severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 7 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose Receives: Drug: Levetiracetam 250 mg
Group E: End-stage renal disease	Experimental	Group E will receive Levetiracetam (LEV) 500 mg on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg will be administered 1 h after the end of the first hemodialysis on Day 3. The 4-h Hemodialysis are scheduled as follows: 1. Dialysis: 44 h to 48 h after the first dose (Day 3) 2. Dialysis: 92 h to 96 h after the first dose (Day 5) 3. Dialysis: 140 h after the first dose (Day 7) Safety assessments and blood samplings will be conducted until Day 7. Safety follow-up assessments will be performed on Day 10. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44, 44.25, 44.5, 45, 46, 47, 48, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing. 49 h-sample should be taken before the additional dose. The 44 h, 92 h, and 140 h sample should be taken before the start of the hemodialysis. Inflow blood, outflow blood, and dialysate fluid will be collected. Receives: Drug: Levetiracetam 250 mg; Drug: Levetiracetam 500 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
Cmax refers to the maximum observed concentration of L059 (Levetiracetam).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
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
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
Cmax refers to the maximum observed concentration of ucb L057.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
Measured: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Measured: From Baseline to 44 hours post first dose
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Cmax refers to the maximum observed concentration of ucb L057.
Measured: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Measured: From Baseline to 44 hours post first dose

Secondary outcomes (21)

Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
Ae refers to the total amount of ucb L059 (Levetiracetam) excreted in urine.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
fe refers to the fraction of dose excreted in urine of L059 (Levetiracetam).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
The Non-Renal Clearance (CLNR) describes the removal of drug by organs other than the kidneys.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
Ae refers to the total amount of ucb L057 excreted in urine.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Renal Clearance (CLR) of Ucb L057 for Groups A to D
Renal clearance describes the removal of drug from a volume of plasma in a given unit of time by the kidneys.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
Clearance (expressed as volume/time) describes the removal of drug from a volume of plasma in a given unit of time (drug loss from the body). It indicates the volume of plasma (or blood) from which the drug is completely removed, or cleared, in a given time period.
Geometric mean and Coefficient of Variation (CV) was not calculated since the extrapolated part of the AUC was greater than 20 %.
Measured: From Baseline to 44 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
tmax refers to the time to reach maximum plasma concentration of ucb L059 (Levetiracetam).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
Terminal half-life refers to the time it takes for the concentrations to decrease by half.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
tmax refers to the time to reach maximum plasma concentration (tmax).
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
Terminal half-life refers to the time it takes for the concentrations to decrease by half.
Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Measured: From Baseline up to 144 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
tmax refers to the time to reach the maximum plasma concentration of ucb L059 (Levetiracetam).
Measured: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.
Measured: From Baseline to 140 hours post first dose
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
Terminal half-life refers to the time it takes for the concentrations to decrease by half.
Geometric mean and CV was not calculated since the extrapolated part of the AUC was greater than 20 %.
Measured: From Baseline to 44 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
tmax refers to the time to reach maximum plasma concentration (tmax).
Measured: From Baseline to 44 hours post first dose
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Measured: From 44 hours to 48 hours post first dose
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated by the Arterio - Venous difference method and cumulative dialysate method.
Measured: From 44 hours to 48 hours post first dose
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Calculated according: CLHD=CLD+CLUF.
Measured: From 44 hours to 48 hours post first dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2011Nov 2012

First posted13 Dec 2011 (estimated)
Study startNov 2011
Primary completionNov 2012
Study completionNov 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy SubjectsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01491113
Sponsor's protocol ID: N01373
Status last verified: Jan 2014
First submitted: 9 Dec 2011
Last updated: 10 Feb 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01491113
Acronym / sponsor ID: N01373
Conditions: Healthy Subjects, Renal Impairments
Keywords: Levetiracetam, Oral administration, Japanese, Non-epileptic, Healthy, Renal impaired subjects
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 30 participants (actual)
Lead sponsor: UCB PharmaIndustry (pharma, biotech, devices)
Collaborators: Parexel
Study start: Nov 2011
Primary completion: Nov 2012 (actual)
Study completion: Nov 2012 (actual)
First posted: 13 Dec 2011 (estimated)
Results: Posted 10 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group A: Normal renal function	Experimental	Drug: Levetiracetam 500 mgSubjects who have normal renal function (CLcr >80 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be taken through to Day 4 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72 hours postdose
Group B: Mild renal impairment	Experimental	Drug: Levetiracetam 500 mgPatients who have mild renal impairment (50<CLcr <80 mL/min/1.73 m^2). Subjects will be orally administered (Levetiracetam) LEV 500 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 5 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96 hours postdose
Group C: Moderate renal impairment	Experimental	Drug: Levetiracetam 250 mgPatients who have moderate renal impairment (30<CLcr < 50 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 6 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120 hours postdose
Group D: Severe renal impairment	Experimental	Drug: Levetiracetam 250 mgPatients who have severe renal impairment (CLcr <30 mL/min/1.73 m^2). Subjects will be orally administered Levetiracetam (LEV) 250 mg once. After LEV administration, safety assessments and blood and urine samplings will be conducted through Day 7 during the Treatment Period, and safety follow-up assessments will be performed on Day 8 according to the schedule of study assessments. * Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144 hours postdose * Urine samples for PK: 0 - 6, 6 - 12, 12 - 24, 24 - 48, 48 - 72, 72 - 96, 96 -120, 120 - 144 hours postdose
Group E: End-stage renal disease	Experimental	Drug: Levetiracetam 250 mg, Drug: Levetiracetam 500 mgGroup E will receive Levetiracetam (LEV) 500 mg on Day 1, 44 hours (h) before the first hemodialysis. As a supplementary dose LEV 250 mg will be administered 1 h after the end of the first hemodialysis on Day 3. The 4-h Hemodialysis are scheduled as follows: 1. Dialysis: 44 h to 48 h after the first dose (Day 3) 2. Dialysis: 92 h to 96 h after the first dose (Day 5) 3. Dialysis: 140 h after the first dose (Day 7) Safety assessments and blood samplings will be conducted until Day 7. Safety follow-up assessments will be performed on Day 10. Blood samples for Pharmacokinetics (PK): Predose (Baseline), and 0.5, 1, 2, 4, 6, 8, 12, 24, 30, 44, 44.25, 44.5, 45, 46, 47, 48, 49, 49.5, 50, 51, 53, 55, 57, 61, 73, 92, 96, 120, 140 hours post first dosing. 49 h-sample should be taken before the additional dose. The 44 h, 92 h, and 140 h sample should be taken before the start of the hemodialysis. Inflow blood, outflow blood, and dialysate fluid will be collected.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (1 listed)

Subjects has taken any drug treatment, disease or injury to influence Levetiracetam PK except for renal impairments

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Levetiracetam 250 mgAlso: E-KeppraTablet containing Levetiracetam 250 mg	Drug	Group C: Moderate renal impairment, Group D: Severe renal impairment, Group E: End-stage renal disease
Levetiracetam 500 mgAlso: E-KeppraTablet containing Levetiracetam 500 mg	Drug	Group A: Normal renal function, Group B: Mild renal impairment, Group E: End-stage renal disease

Primary outcome

Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Cmax refers to the maximum observed concentration of L059 (Levetiracetam). Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
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
Time frame: From Baseline up to 144 hours post first dose
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Cmax refers to the maximum observed concentration of ucb L057. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to the Last Quantifiable Concentration for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure. Group A: Baseline to 72 hours; Group B: Baseline to 96 hours; Group C: Baseline to 120 hours; Group D: Baseline to 144 hours
Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Group E During First Period
Time frame: From Baseline to 44 hours post first dose
Cmax refers to the maximum observed concentration of ucb L059 (Levetiracetam).
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L059 (LEV) From Baseline to 44 Hours for Group E
Time frame: From Baseline to 44 hours post first dose
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.
Maximum Observed Plasma Concentration (Cmax) of Ucb L057 for Group E During First Period
Time frame: From Baseline to 44 hours post first dose
Cmax refers to the maximum observed concentration of ucb L057.
Area Under the Concentration-time Curve (AUC(0-t)) of Ucb L057 From Baseline to 44 Hours for Group E
Time frame: From Baseline to 44 hours post first dose
AUC(0-t) refers to the area under the plasma concentration versus time curve, which provides information on the exposure.

21 secondary outcomes

Total Amount Excreted in Urine (Ae) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Fraction of Dose Excreted in Urine (fe) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Renal Clearance (CLR) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Nonrenal Clearance (CLNR) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Total Amount Excreted in Urine (Ae) of Ucb L057 for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Renal Clearance (CLR) of Ucb L057 for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Apparent Total Body Clearance (CL/F) of Ucb L059 (LEV) for Group E During First Period
Time frame: From Baseline to 44 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L057 From Baseline to Infinite for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Terminal Half-life (t1/2) of Ucb L057 for Groups A to D
Time frame: From Baseline up to 144 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L059 (Levetiracetam) for Group E During First Period
Time frame: From Baseline to 44 hours post first dose
Area Under the Concentration-time Curve (AUC) of Ucb L059 (LEV) From Baseline to Infinite for Group E
Time frame: From Baseline to 140 hours post first dose
Terminal Half-life (t1/2) of Ucb L059 (LEV) for Group E During First Period
Time frame: From Baseline to 44 hours post first dose
Time to Reach Maximum Plasma Concentration (Tmax) of Ucb L057 for Group E During First Period
Time frame: From Baseline to 44 hours post first dose
Hemodialysis Clearance (CLD) of Ucb L059 (LEV) During First Dialysis for Group E
Time frame: From 44 hours to 48 hours post first dose
Ultrafiltration Clearance (CLUF) of Ucb L059 (LEV) During First Dialysis for Group E
Time frame: From 44 hours to 48 hours post first dose
Hemodialysis Clearance (CLHD) of Ucb L059 (LEV) During First Dialysis for Group E
Time frame: From 44 hours to 48 hours post first dose

Results and safety

Results posted to the registry on 10 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: Normal Renal Function	6	6
Group B: Mild Renal Impairment	6	6
Group C: Moderate Renal Impairment	6	6
Group D: Severe Renal Impairment	6	6
Group E: End-stage Renal Disease	6	6

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

Time frame: From Baseline up to 144 hours post first dose. Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	Group A: Normal Renal Function n = 6	Group B: Mild Renal Impairment n = 6	Group C: Moderate Renal Impairment n = 6	Group D: Severe Renal Impairment n = 6
Value	21.9357 (31.2)	15.5334 (25.3)	10.7767 (24.3)	9.1754 (30.4)

Population analysed: The Analysis Population refers to the Pharmacokinetic Per Protocol Set which consists of all subjects included in the Safety Set, who also have a sufficient number of bioanalytical assessments (plasma or urine) to calculate reliable estimates for the Pharmacokinetic parameters.

Primary outcome: 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

Time frame: From Baseline up to 144 hours post first dose. Geometric mean (Geometric Coefficient of Variation). Unit: h*µg/mL

Measure	Group A: Normal Renal Function n = 6	Group B: Mild Renal Impairment n = 6	Group C: Moderate Renal Impairment n = 6	Group D: Severe Renal Impairment n = 6
Value	165.9996 (16.5)	247.6430 (16.9)	169.3392 (16.5)	212.1193 (19.1)

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

Time frame: From Baseline up to 144 hours post first dose. Geometric mean (Geometric Coefficient of Variation). Unit: µg/mL

Measure	Group A: Normal Renal Function n = 6	Group B: Mild Renal Impairment n = 6	Group C: Moderate Renal Impairment n = 6	Group D: Severe Renal Impairment n = 6
Value	0.3620 (9.4)	0.7503 (25.8)	0.5674 (26.0)	1.0640 (29.3)

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

Time frame: From Baseline up to 144 hours post first dose. Geometric mean (Geometric Coefficient of Variation). Unit: h*µg/mL

Measure	Group A: Normal Renal Function n = 6	Group B: Mild Renal Impairment n = 6	Group C: Moderate Renal Impairment n = 6	Group D: Severe Renal Impairment n = 6
Value	5.8607 (9.7)	22.5573 (45.9)	18.6675 (53.4)	57.7773 (57.3)

21 secondary outcomes are reported in the full results.

Adverse events

Time frame: Treatment-Emergent Adverse Events were reported from Day 1 up to Day 8 (+2 days) for Group A to D and from Day 1 up to Day 10 (+2 days) for Group E.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: Normal Renal Function	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group B: Mild Renal Impairment	0 of 6 (0%)	2 of 6 (33.3%)	Not reported
Group C: Moderate Renal Impairment	0 of 6 (0%)	0 of 6 (0%)	Not reported
Group D: Severe Renal Impairment	0 of 6 (0%)	1 of 6 (16.7%)	Not reported
Group E: End-stage Renal Disease	1 of 6 (16.7%)	2 of 6 (33.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
FDA Safety Alerts and RecallsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

UCB Clinical Trial Call Center study director

+1 877 822 9493 (UCB)

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Levetiracetam 250 mg and Levetiracetam 500 mg in people with Healthy Subjects and Renal Impairments, run by UCB Pharma at 2 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) of Ucb L059 (LEV) for Groups A to D (time frame: From Baseline up to 144 hours post first dose). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01491113.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2014.