Healthy VolunteersPhase 1NCT01394224
Bioequivalence Study of Levetiracetam Tablet and Intravenous Infusion in Healthy Japanese Subjects
A Phase 1 study testing Levetiracetam in people with Healthy Volunteers, run by UCB Pharma at 1 site in United Kingdom.
Trial summary
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2011to Sep 2011
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese male and female volunteers with the age between 20 and 55 years old
Who cannot join
- Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Subject is pregnant or lactating female.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Levetiracetam
- Keywords
- Healthy volunteers, Japanese
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Also called E-Keppra
Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
LevetiracetamDrug
Also called E-Keppra
Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam IV Infusion (1500 mg) | Experimental | Not described Receives: Drug: Levetiracetam |
| Levetiracetam tablets (1500 mg) | Experimental | Not described Receives: Drug: Levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration (Cmax)
Measured: Multiple sampling from 0 to 36 hours following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)
Measured: Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose
Secondary outcomes (8)
Time to reach maximum plasma concentration (tmax)
Measured: Multiple sampling from 0 to 36 hours following single dose
Plasma concentration at the end of infusion (C15' )
Measured: At 15 minutes after termination of the15-minutes infusion
Area under the curve from 0 to infinity (AUC)
Measured: Multiple sampling from 0 to 36 hours following single dose
Mean resident time (MRT)
Measured: Multiple sampling from 0 to 36 hours following single dose
Terminal elimination half-life(t1/2)
Measured: Multiple sampling from 0 to 36 hours following single dose
First order terminal elimination rate constant (λz )
Measured: Multiple sampling from 0 to 36 hours following single dose
Total body clearance after oral administration (CL/F) or after IV infusion (CL)
Measured: Multiple sampling from 0 to 36 hours following single dose
Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)
Measured: Multiple sampling from 0 to 36 hours following single dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionSep 2011
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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- UCB Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- UCB Clinical Trial Call Center, Study director, +1 877 822 9493 (UCB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01394224
- Sponsor's protocol ID
- N01377
- Other IDs
- 2011-000827-34
- Status last verified
- Oct 2011
- First submitted
- 12 Jul 2011
- Last updated
- 6 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Site, Open-label, Randomized, Single-dose, Two-way Cross-over Study in Healthy Japanese Subjects to Evaluate the Bioequivalence, Safety & Tolerability of Levetiracetam Administered as an Oral Tablet or Intravenous Infusion
- ClinicalTrials.gov ID
- NCT01394224
- Acronym / sponsor ID
- N01377
- Conditions
- Healthy Volunteers
- Keywords
- Healthy volunteers, Japanese
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jul 2011 (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.
The purpose of this study is to investigate the pharmacokinetics(PK) and evaluate the bioequivalence of levetiracetam (LEV) following a single 15-minutes IV infusion of 1500 mg and a single oral dose(tablets) of 1500 mg in healthy Japanese subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam IV Infusion (1500 mg) | Experimental | Drug: Levetiracetam |
| Levetiracetam tablets (1500 mg) | Experimental | Drug: Levetiracetam |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Japanese male and female volunteers with the age between 20 and 55 years old
Key exclusion criteria (3 listed)
- Subject has participated or is participating in any other clinical studies of investigational drug or another IMP within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any medical or emotional/psychological problems, a drug/alcohol abuse, having abnormal safety parameters)
- Subject is pregnant or lactating female.
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 |
|---|---|---|
| LevetiracetamAlso: E-KeppraStrength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose | Drug | Levetiracetam IV Infusion (1500 mg) |
| LevetiracetamAlso: E-KeppraLevetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose | Drug | Levetiracetam tablets (1500 mg) |
Primary outcome
Maximum drug concentration (Cmax)
Time frame: Multiple sampling from 0 to 36 hours following single dose
Area under the plasma drug concentration versus time curve from hour 0 to the time with a last quantifiable level (AUCo-t)
Time frame: Multiple sampling from 0 to 36 hours (could be less than 36 hours if the last quantifiable concentration is below limit of quantification), following single dose
8 secondary outcomes
Time to reach maximum plasma concentration (tmax)
Time frame: Multiple sampling from 0 to 36 hours following single dose
Plasma concentration at the end of infusion (C15' )
Time frame: At 15 minutes after termination of the15-minutes infusion
Area under the curve from 0 to infinity (AUC)
Time frame: Multiple sampling from 0 to 36 hours following single dose
Mean resident time (MRT)
Time frame: Multiple sampling from 0 to 36 hours following single dose
Terminal elimination half-life(t1/2)
Time frame: Multiple sampling from 0 to 36 hours following single dose
First order terminal elimination rate constant (λz )
Time frame: Multiple sampling from 0 to 36 hours following single dose
Total body clearance after oral administration (CL/F) or after IV infusion (CL)
Time frame: Multiple sampling from 0 to 36 hours following single dose
Volume of distribution after oral administration(Vz/F) or after IV infusion(Vz)
Time frame: Multiple sampling from 0 to 36 hours following single dose
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 6 Oct 2011.
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Screening Protocol
Pain
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)
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 Levetiracetam in people with Healthy Volunteers, run by UCB Pharma at 1 site in United Kingdom.
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 1 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 6 Oct 2011. 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 United Kingdom. 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 drug concentration (Cmax) (time frame: Multiple sampling from 0 to 36 hours following single dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2011.