Healthy VolunteersPhase 1NCT01375387
Three-way-cross-over Study to Evaluate Safety and Pharmacokinetics of Lacosamide in Healthy Japanese and Chinese Males
A Phase 1 study testing Lacosamide in people with Healthy Volunteers, run by UCB Pharma at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lacosamide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2011to Jun 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 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Chinese or Japanese volunteers
Who cannot join
- Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Randomized Double-blind, Placebo-controlled, Single-center, Single-dose, Three-way Cross-over Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lacosamide Tablets in Healthy Male Chinese and Japanese Subjects
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
- Conditions
- Healthy Volunteers
- Being tested
- Lacosamide, Placebo 3, Placebo 4, Placebo 2
- Keywords
- Vimpat, Pharmacokinetics, Healthy Japanese male, Healthy Chinese male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat®
100 mg oral tablet, single dose
LacosamideDrug
Also called Vimpat®
Lacosamide 2 X 100 mg tablet
LacosamideDrug
Also called Vimpat®
Lacosamide 4 X 100mg tablet
Placebo 3Other
Placebo - 3 tablets
Placebo 4Other
Placebo - 4 tablets
Placebo 2Other
Placebo - 2 tablets
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide 100 mg, Japanese | Experimental | 1 Lacosamide 100 mg tablet plus 3 placebo tablets Receives: Drug: Lacosamide; Other: Placebo 3 |
| Lacosamide 100 mg, Chinese | Experimental | 1 Lacosamide 100 mg tablet plus 3 placebo tablets Receives: Drug: Lacosamide; Other: Placebo 3 |
| Lacosamide 200 mg, Japanese | Experimental | 2 Lacosamide 100 mg tablets plus 2 placebo tablets Receives: Drug: Lacosamide; Other: Placebo 2 |
| Lacosamide 200 mg, Chinese | Experimental | 2 Lacosamide 100 mg tablets plus 2 placebo tablets Receives: Drug: Lacosamide; Other: Placebo 2 |
| Lacosamide 400 mg, Japanese | Experimental | 4 Lacosamide 100 mg tablets Receives: Drug: Lacosamide |
| Lacosamide 400 mg, Chinese | Experimental | 4 Lacosamide 100 mg tablets Receives: Drug: Lacosamide |
| Placebo Comparator, Japanese | Placebo comparator | 4 placebo tablets Receives: Other: Placebo 4 |
| Placebo Comparator, Chinese | Placebo comparator | 4 placebo tablets Receives: Other: Placebo 4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum drug concentration (Cmax) of lacosamide in plasma.
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Secondary outcomes (17)
Time to reach maximum plasma concentration (tmax) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent total body clearance (CL/F) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent volume of distribution (Vz/F) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Mean resident time (MRT) of lacosamide in plasma.
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of lacosamide in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Maximum drug concentration (Cmax) of SPM12809 in plasma.
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of SPM12809 in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of SPM12809 in plasma
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Fraction of dose excreted in urine (fe) of lacosamide and SPM12809
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Renal clearance (CLR) of lacosamide and SPM12809
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent formation clearance of metabolites (CLfm/F)
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
AUC Ratio
Measured: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startMar 2011
- Primary completionJun 2011
- Study completionJun 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 33 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
- NCT01375387
- Sponsor's protocol ID
- SP1046
- Other IDs
- 2010-023164-40
- Status last verified
- Jun 2011
- First submitted
- 19 Apr 2011
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized Double-blind, Placebo-controlled, Single-center, Single-dose, Three-way Cross-over Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Lacosamide Tablets in Healthy Male Chinese and Japanese Subjects
- ClinicalTrials.gov ID
- NCT01375387
- Acronym / sponsor ID
- SP1046
- Conditions
- Healthy Volunteers
- Keywords
- Vimpat, Pharmacokinetics, Healthy Japanese male, Healthy Chinese male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 17 Jun 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 evaluate the safety, tolerability and pharmacokinetics of lacosamide following single oral administration of lacosamide 100 mg, 200 mg and 400 mg in healthy male Chinese and Japanese subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Lacosamide 100 mg, Japanese | Experimental | Drug: Lacosamide, Other: Placebo 31 Lacosamide 100 mg tablet plus 3 placebo tablets |
| Lacosamide 100 mg, Chinese | Experimental | Drug: Lacosamide, Other: Placebo 31 Lacosamide 100 mg tablet plus 3 placebo tablets |
| Lacosamide 200 mg, Japanese | Experimental | Drug: Lacosamide, Other: Placebo 22 Lacosamide 100 mg tablets plus 2 placebo tablets |
| Lacosamide 200 mg, Chinese | Experimental | Drug: Lacosamide, Other: Placebo 22 Lacosamide 100 mg tablets plus 2 placebo tablets |
| Lacosamide 400 mg, Japanese | Experimental | Drug: Lacosamide4 Lacosamide 100 mg tablets |
| Lacosamide 400 mg, Chinese | Experimental | Drug: Lacosamide4 Lacosamide 100 mg tablets |
| Placebo Comparator, Japanese | Placebo comparator | Other: Placebo 44 placebo tablets |
| Placebo Comparator, Chinese | Placebo comparator | Other: Placebo 44 placebo tablets |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy Chinese or Japanese volunteers
Key exclusion criteria (2 listed)
- Subject has participated or is participating in any other clinical studies of Lacosamide within the last 3 months
- Subject is not healthy (eg, taking any drug treatments, excessive amount of alcohol, cigarettes or caffeine, having any psychological or emotional problems, a drug/alcohol abuse, abnormal diet, having abnormal safety parameters)
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 |
|---|---|---|
| LacosamideAlso: Vimpat®100 mg oral tablet, single dose | Drug | Lacosamide 100 mg, Chinese, Lacosamide 100 mg, Japanese |
| LacosamideAlso: Vimpat®Lacosamide 2 X 100 mg tablet | Drug | Lacosamide 200 mg, Chinese, Lacosamide 200 mg, Japanese |
| LacosamideAlso: Vimpat®Lacosamide 4 X 100mg tablet | Drug | Lacosamide 400 mg, Chinese, Lacosamide 400 mg, Japanese |
| Placebo 3Placebo - 3 tablets | Other | Lacosamide 100 mg, Chinese, Lacosamide 100 mg, Japanese |
| Placebo 4Placebo - 4 tablets | Other | Placebo Comparator, Chinese, Placebo Comparator, Japanese |
| Placebo 2Placebo - 2 tablets | Other | Lacosamide 200 mg, Chinese, Lacosamide 200 mg, Japanese |
Primary outcome
Maximum drug concentration (Cmax) of lacosamide in plasma.
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
17 secondary outcomes
Time to reach maximum plasma concentration (tmax) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent total body clearance (CL/F) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent volume of distribution (Vz/F) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Mean resident time (MRT) of lacosamide in plasma.
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of lacosamide in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Maximum drug concentration (Cmax) of SPM12809 in plasma.
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to the time of the last quantifiable concentration (AUC(0-t)) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Area under the curve from 0 to infinity (AUC) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Time to reach maximum plasma concentration (tmax) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Terminal half-life (t½) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
First order terminal elimination rate constant (λZ ) of SPM12809 in plasma
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Total amount of drug excreted in urine (Ae) of lacosamide and SPM12809
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Fraction of dose excreted in urine (fe) of lacosamide and SPM12809
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Renal clearance (CLR) of lacosamide and SPM12809
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
Apparent formation clearance of metabolites (CLfm/F)
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
AUC Ratio
Time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period
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 23 Aug 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 Lacosamide in people with Healthy Volunteers, run by UCB Pharma at 1 site in Germany.
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 2 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 23 Aug 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 Germany. 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. Some participants in this study may receive a placebo. 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) of lacosamide in plasma. (time frame: Multiple sampling from 0 to 72 hours following single dose in each treatment period). The study lists 3 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 23 Aug 2011.