Healthy VolunteersPhase 1NCT01725009

Multiple-dose Study of Levetiracetam Injection in Japanese and Caucasian Healthy Males

A Phase 1 study testing Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in people with Healthy Volunteers, run by UCB Japan Co. Ltd. at 1 site 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

To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects Read more about this study

Who is it for?: Ages 20 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteJapan
Study dates: Oct 2012to Dec 2012
Phase: Phase 1
Are there results?: None posted in the registry

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 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

healthy Japanese and Caucasian males with the age between 20 and 40 years old,
with the body mass index between 20 and 25,
with the body weight between 60 and 80kg

Who cannot join

subjects who have a history or presence of drug addiction or excessive use of alcohol
current smokers and former smokers who have given up since less than 6 months before the first dose
heavy caffeine drinker

Trial locations and contacts

1 site in 1 country.

Japan1 site

01
Tokyo

Other trials in Japan

About this study

Official title: A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects

To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects

Conditions: Healthy Volunteers
Being tested: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Keywords: Healthy volunteers, Japanese, Caucasian

What participants receive

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

Multiple 15-minute intravenous infusions of 1500 mg levetiracetamDrug
Also called E-Keppra
Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days

Study groups in NCT01725009
Study group	Role	What they receive
Levetiracetam IV infusions in Japanese	Experimental	Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects Receives: Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam
Levetiracetam IV infusions in Caucasian	Experimental	Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects Receives: Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetam

What is being measured

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

Maximum plasma concentration after a single dose (Cmax)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion
Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized maximum plasma concentration after a single dose (Cmax)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Maximum plasma concentration at steady state after multiple doses (Cmax,ss)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

Secondary outcomes (11)

Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion
Time to maximum plasma concentration after a single dose (tmax)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Terminal elimination half-life after a single dose (t1/2)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
First order terminal elimination rate constant after a single dose (λz)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Total body clearance after a single dose (CL)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Volume of distribution during terminal phase after a single dose (Vz)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Mean residence time after a single dose (MRT)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Total body clearance at steady state after multiple doses (CLss)
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Linearity factor after multiple doses (LF)
LF = AUCτss / AUC
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion.
Accumulation ratio (RAUC) after multiple doses
RAUC = AUCτss / AUCτ
Measured: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions

Timeline

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

Oct 2012Dec 2012

First posted12 Nov 2012 (estimated)
Study startOct 2012
Primary completionDec 2012
Study completionDec 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies 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 1
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01725009
Sponsor's protocol ID: EP0038
Status last verified: Mar 2013
First submitted: 7 Nov 2012
Last updated: 29 Mar 2013
Results posted: No
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 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-center, Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Levetiracetam Administered as Intravenous Infusion in Japanese and Caucasian Healthy Male Subjects
ClinicalTrials.gov ID: NCT01725009
Acronym / sponsor ID: EP0038
Conditions: Healthy Volunteers
Keywords: Healthy volunteers, Japanese, Caucasian
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: UCB Japan Co. Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2012
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 12 Nov 2012 (estimated)
Results: Not posted in the source record

Clinical summary

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

To compare the pharmacokinetics of levetiracetam following single and multiple 15-minute intravenous infusions of 1500 mg levetiracetam between Japanese and Caucasian healthy male subjects

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Levetiracetam IV infusions in Japanese	Experimental	Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetamMultiple 15-minute intravenous infusions of 1500 mg levetiracetam in Japanese subjects
Levetiracetam IV infusions in Caucasian	Experimental	Drug: Multiple 15-minute intravenous infusions of 1500 mg levetiracetamMultiple 15-minute intravenous infusions of 1500 mg levetiracetam in Caucasian subjects

Who may qualify

Ages: 20 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

healthy Japanese and Caucasian males with the age between 20 and 40 years old,
with the body mass index between 20 and 25,
with the body weight between 60 and 80kg

Key exclusion criteria (3 listed)

subjects who have a history or presence of drug addiction or excessive use of alcohol
current smokers and former smokers who have given up since less than 6 months before the first dose
heavy caffeine drinker

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
Multiple 15-minute intravenous infusions of 1500 mg levetiracetamAlso: E-KeppraStrength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days	Drug	Levetiracetam IV infusions in Caucasian, Levetiracetam IV infusions in Japanese

Primary outcome

Maximum plasma concentration after a single dose (Cmax)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion
Area under the curve from zero to the time of the last quantifiable concentration after a single (AUC(0-t))
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Area under the plasma concentration time curve from zero to infinity after a single dose (AUC)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized maximum plasma concentration after a single dose (Cmax)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body-weight normalized area under the curve from zero to the time of the last quantifiable concentration after a single, (AUC(0-t))
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Body weight normalized area under the plasma concentration time curve from zero to infinity after a single dose, (AUC)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion
Maximum plasma concentration at steady state after multiple doses (Cmax,ss)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Body-weight normalized maximum plasma concentration at steady state after multiple doses (Cmax,ss)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Body-weight normalized area under the curve over a dosing interval at steady state after multiple doses (AUCτss)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.

11 secondary outcomes

Area under the curve over a dosing interval, (AUCτ (τ = 12 hours))
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion
Time to maximum plasma concentration after a single dose (tmax)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Terminal elimination half-life after a single dose (t1/2)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
First order terminal elimination rate constant after a single dose (λz)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Total body clearance after a single dose (CL)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Volume of distribution during terminal phase after a single dose (Vz)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Mean residence time after a single dose (MRT)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of IV infusion.
Time to maximum plasma concentration at steady state after multiple doses (tmax,ss)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Total body clearance at steady state after multiple doses (CLss)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of IV infusion.
Linearity factor after multiple doses (LF)
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of the first IV infusion and at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the last IV infusion.
Accumulation ratio (RAUC) after multiple doses
Time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9 and 12 hours after the start of the first and the last IV infusions

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Multiple 15-minute intravenous infusions of 1500 mg levetiracetam in people with Healthy Volunteers, run by UCB Japan Co. Ltd. at 1 site 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 3 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 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 plasma concentration after a single dose (Cmax) (time frame: Multiple samples at predose, 5, 10, 15, 30, 45 minutes, 1, 1.5, 2, 3, 6, 9, 12, 24 and 36 hours after the start of Intravenous (IV) infusion). The study lists 10 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 NCT01725009.

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 29 Mar 2013.