Healthy VolunteersPhase 1NCT01526083
Effect of Lacosamide 200 mg Twice a Day (Bid) on Single Dose Warfarin 25 mg in Healthy Males
A Phase 1 study testing Lacosamide and Warfarin in people with Healthy Volunteers, run by UCB Pharma at 1 site in Netherlands.
Trial summary
The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Lacosamide and Warfarin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2012to Mar 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 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male volunteers 18-55 years of age
- BMI 18.0-30.0 kg/m2 and weight at least 50 kg
- Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive
Who cannot join
- Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- Volunteer 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)
- Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
- Volunteer has history of suicide attempt
- Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers
The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Lacosamide, Warfarin
- Keywords
- Male Healthy Volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideOther
Also called Vimpat
Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
WarfarinOther
Also called Coumadin
Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period
In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart.
Duration: single dose
| Study group | Role | What they receive |
|---|---|---|
| Single dose of Warfarin on day 3 | Other | Single dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID Receives: Other: Lacosamide |
| Single dose of Warfarin | Other | Not described Receives: Other: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin)
Measured: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Maximum Warfarin plasma concentration (Cmax)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Maximum prothrombin time (PTmax)
Measured: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin area under the prothrombin time (PT) versus time curve (PTAUC)
Measured: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin maximum international normalized ratio (INRmax)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Secondary outcomes (29)
Lacosamide trough plasma concentration (Ctrough)
Measured: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
Time of maximum Warfarin plasma concentration (Tmax)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Terminal half-life of Warfarin (T ½)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent total body clearance of Warfarin (CL /F)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent volume of distribution of Warfarin (V /F)
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
First order terminal elimination rate constant of Warfarin
Measured: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
CYP2C9 genotype
Measured: Single measurement on Day 1
VKORC1 genotype
Measured: Single measurement on Day 1
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study
Measured: Duration of study is approximately 32 days
Change from Baseline in Pulse Rate at 4 h post dose
40-90 bpm
Measured: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 12 h post dose
40-90 bpm
Measured: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 24 h post dose
40-90 bpm
Measured: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 4 h post dose
40-90 bpm
Measured: From pre dose to 4 h post dose Lacosamide (LCM) administration
Change from Baseline in Pulse Rate at 12 h post dose
40-90 bpm
Measured: From pre dose to 12 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 4 h post dose
Measured: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 12 h post dose
Measured: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 24 h post dose
Measured: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 4 h post dose
Measured: From pre dose to 4 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 12 h post dose
40-90 bpm
Measured: From pre dose to 12 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Measured: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Measured: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 24 h post dose
Measured: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Measured: From pre dose to 4 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
40-90 bpm
Measured: From pre dose to 12 h post dose LCM administration
Change from Baseline in Body Temperature at 4h post dose
Measured: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 12 h post dose
Measured: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 24 h post dose
Measured: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 4 h post dose
Measured: From pre dose to 4 h post dose LCM administration
Change from Baseline in Body Temperature at 12 h post dose
40-90 bpm
Measured: From pre dose to 12 h post dose LCM administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionMar 2012
- Study completionMar 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01526083
- Sponsor's protocol ID
- EP0013
- Other IDs
- 2011-004911-21
- Status last verified
- May 2012
- First submitted
- 31 Jan 2012
- Last updated
- 7 May 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center, Open-label, Randomized 2-way Crossover Study of the Effect of Lacosamide 200 mg Twice Daily on the Single-dose Pharmacokinetics and Pharmacodynamics of Warfarin (25 mg) in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT01526083
- Acronym / sponsor ID
- EP0013
- Conditions
- Healthy Volunteers
- Keywords
- Male Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 3 Feb 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.
The purpose of this study is to investigate the effect of Lacosamide 200 mg twice a day (bid) on single dose pharmacokinetics (PK) and pharmacodynamics (PD) of Warfarin (25 mg) in healthy male volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single dose of Warfarin on day 3 | Other | Other: LacosamideSingle dose of Warfarin on day 3 of a 7 day course of Lacosamide 200 mg BID |
| Single dose of Warfarin | Other | Other: Warfarin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male volunteers 18-55 years of age
- BMI 18.0-30.0 kg/m2 and weight at least 50 kg
- Tympanic body temperature 35.0-37.5°C (95 and 99.5°F) inclusive
Key exclusion criteria (5 listed)
- Volunteer has participated or is participating in any other clinical studies of investigational drug or another Investigational Medicinal Product (IMP) within the last 3 months
- Volunteer 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)
- Volunteer is taking Warfarin or Non Steroidal Anti-Inflammatory Drug (NSAID)
- Volunteer has history of suicide attempt
- Volunteer has history of coagulation abnormalities, occult blood in stool, gastrointestinal ulcer, surgery within 6 months
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: VimpatStrength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days | Other | Single dose of Warfarin on day 3 |
| WarfarinAlso: CoumadinStrength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart. Duration: single dose | Other | Single dose of Warfarin |
Primary outcome
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Area under the Warfarin plasma concentration versus time curve from time 0 to the last quantifiable level, AUC0-t(Warfarin)
Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Maximum Warfarin plasma concentration (Cmax)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Maximum prothrombin time (PTmax)
Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin area under the prothrombin time (PT) versus time curve (PTAUC)
Time frame: Multiple sampling from 0 -168 hours following administration of a single warfarin dose in each treatment period
Warfarin maximum international normalized ratio (INRmax)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
Warfarin area under the International Normalized Ratio (INR) versus time curve (INRAUC)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period
29 secondary outcomes
Lacosamide trough plasma concentration (Ctrough)
Time frame: Morning pre dose sample on Days 3-10 or Days 24 -30 of Lacosamide BID dosing
Time of maximum Warfarin plasma concentration (Tmax)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Terminal half-life of Warfarin (T ½)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent total body clearance of Warfarin (CL /F)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
Apparent volume of distribution of Warfarin (V /F)
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
First order terminal elimination rate constant of Warfarin
Time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose
CYP2C9 genotype
Time frame: Single measurement on Day 1
VKORC1 genotype
Time frame: Single measurement on Day 1
Occurrence of at Least One Treatment-emergent Adverse Event (TEAE) during the duration of the study
Time frame: Duration of study is approximately 32 days
Change from Baseline in Pulse Rate at 4 h post dose
Time frame: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 12 h post dose
Time frame: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 24 h post dose
Time frame: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Pulse Rate at 4 h post dose
Time frame: From pre dose to 4 h post dose Lacosamide (LCM) administration
Change from Baseline in Pulse Rate at 12 h post dose
Time frame: From pre dose to 12 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 4 h post dose
Time frame: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 12 h post dose
Time frame: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 24 h post dose
Time frame: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Systolic Blood Pressure at 4 h post dose
Time frame: From pre dose to 4 h post dose LCM administration
Change from Baseline in Systolic Blood Pressure at 12 h post dose
Time frame: From pre dose to 12 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Time frame: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Time frame: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 24 h post dose
Time frame: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Diastolic Blood Pressure at 4 h post dose
Time frame: From pre dose to 4 h post dose LCM administration
Change from Baseline in Diastolic Blood Pressure at 12 h post dose
Time frame: From pre dose to 12 h post dose LCM administration
Change from Baseline in Body Temperature at 4h post dose
Time frame: From pre dose to 4 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 12 h post dose
Time frame: From pre dose to 12 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 24 h post dose
Time frame: From pre dose to 24 h post dose Warfarin administration in each treatment period
Change from Baseline in Body Temperature at 4 h post dose
Time frame: From pre dose to 4 h post dose LCM administration
Change from Baseline in Body Temperature at 12 h post dose
Time frame: From pre dose to 12 h post dose LCM administration
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 7 May 2012.
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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
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 and Warfarin in people with Healthy Volunteers, run by UCB Pharma at 1 site in Netherlands.
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 5 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 7 May 2012. 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 Netherlands. 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?
Area under the Warfarin plasma concentration versus time curve from time 0 to infinity, AUC (Warfarin) (time frame: Multiple sampling from 0 -168 hours following administration of a single Warfarin dose in each treatment period). The study lists 7 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 7 May 2012.