EpilepsyPhase 1NCT01450111
To Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects
A Phase 1 study testing Lacosamide in people with Epilepsy, run by UCB Pharma.
Trial summary
Primary objective of this trial was to investigate the pharmacokinetics of single dose and repeated dose applications of lacosamide in healthy male Korean subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- 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
- 51 participants
- Where
- No sites listed yet
- Study dates
- Nov 2008to Feb 2009
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is healthy male and between 20 and 45 years of age (inclusive)
- Subject has no clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
- Subject is of normal body weight as determined by a body mass index (BMI) between 19 and 28 kgm^2
- Subject is Korean (both parents are of pure Korean ethnicity)
Who cannot join
- Subject has a history of or present psychiatric or neurological condition that, in the opinion of the Investigator, could jeopardize or would have compromised the subject's ability to participate in this trial
- Subject has a known or suspected drug hypersensitivity, in particular to the trial medication
- Subject consumes more than 40 g alcohol/day (amount corresponds to 1 L beer/day or 0.5 L wine/day or 6 glasses (à 2cL) liquor/day)
- Subject has donated blood or had a comparable blood loss (>400 mL) within the last 3 months prior to Eligibility Assessment (EA)
- Subject smokes more than 5 cigarettes per day or had done so within 6 months prior to EA.
- Subject consumes more than 600 mg caffeine/day (200 mL coffee contain approximately 100 mg caffeine, 200 mL black tea approximately 30 mg, and 200 mL cola approximately 20 mg)
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- Subject has a diet which deviates notably from the "normal" amounts of protein, carbohydrate, and fat, as judged by the Investigator (eg, vegetarians or vegans)
- Subject has taken herbal medicine therapy within 2 weeks prior to the first dosing
- Subject has a clinically relevant allergy
- Subject is taking any concomitant medication currently or within 2 weeks prior to the first dosing (with the exception of acetaminophen which is allowed to be taken orally up to 1000 mg per dose up to 48 hours prior to commencement of dosing)
- Subject has positive tests for alcohol and/or drugs (urine test) at EA and at confinement
- Subject has a high risk behavior for the HIV
- Subject is tested to be positive for HIV antibodies (HIV Ab), hepatitis B surface antigen (HBs Ag), or hepatitis C virus antibody (HCV Ab)
- Subject has a history or present condition of hepatic disorders, eg, clinically relevant liver enzyme increase (alanine aminotransferase [ALT], aspartate aminotransferase [AST], alkaline phosphatase [AP], and gamma-glutamyl transpeptidase [GGT])
- Subject has a transaminase (either ALT or AST) more than 2 times of the upper limit of normal range (ULN) at confinement
- Subject has clinically relevant out-of-range values for hematology including coagulation parameters, and clinical chemistry, serology or urinalysis parameters
- Subject has any clinically relevant abnormality in the physical examination or vital signs
- Subject has a pulse rate at rest less than 45 bpm or more than 100 bpm at EA
- Subject has a systolic blood pressure lower than 100 mmHg or higher than 160 mmHg or a diastolic blood pressure higher than 95 mmHg at EA
- Subject has clinically relevant findings in the ECG, such as second or third degree atrioventricular (AV) block or PR interval >220 ms, prolongation of the QRS duration to >110 ms, or a QTcB (Bazett corrected) interval over 450 ms or any other clinically relevant ECG finding at EA
- Subject performed heavy physical exertion 2 days before EA or before confinement
- Subject has a history or present condition of respiratory or cardiovascular disorders, eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or status after myocardial infarction
- Subject has a history or present condition of malignancy
- Subject has a history or present condition of seizure disorder
- Subject has atrial fibrillation/flutter, ventricular tachyarrhythmia (eg, ventricular tachycardia, ventricular fibrillation, aborted cardiac arrest), symptomatic heart block at Eligibility Assessment Visit, or is diagnosed with Brugada syndrome (also known as Sudden Unexpected Death Syndrome)
About this study
Official title: Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single/Repeated Dose Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects
Primary objective of this trial was to investigate the pharmacokinetics of single dose and repeated dose applications of lacosamide in healthy male Korean subjects.
- Conditions
- Epilepsy
- Being tested
- Lacosamide, Placebo
- Keywords
- Lacosamide
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacosamideDrug
Also called Vimpat®
Lacosamide 50 mg, tablet, once in the morning on Day 1
LacosamideDrug
Also called Vimpat®
Lacosamide 100 mg, tablet, once in the morning on Day 1 Lacosamide 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
LacosamideDrug
Also called Vimpat®
Lacosamide 200 mg, tablet, once in the morning on Day 1 Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
PlaceboOther
Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1.
PlaceboOther
Placebo matched with Lacosamide 100 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamode 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
PlaceboOther
Placebo matched with Lacosamide 200 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
| Study group | Role | What they receive |
|---|---|---|
| Lacosamide 50 mg group | Experimental | Lacosamide 50 mg tablet, once a day per os (po) Receives: Drug: Lacosamide |
| Placebo group matched with lacosamide 50 mg | Placebo comparator | Placebo matched with lacosamide 50 mg tablet, po Receives: Other: Placebo |
| Lacosamide 100 mg group | Experimental | Lacosamide 100 mg tablet, po Receives: Drug: Lacosamide |
| Placebo group matched with lacosamide 100 mg | Placebo comparator | Placebo matched with lacosamide 100 mg tablet, po Receives: Other: Placebo |
| Lacosamide 200 mg group | Experimental | Lacosamide 200 mg tablet, po Receives: Drug: Lacosamide |
| Placebo group matched with lacosamide 200 mg | Placebo comparator | Placebo matched with lacosamide 200 mg tablet, po Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum concentration of lacosamide at steady state (Cmax) during up to 9 days of administration
Measured: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Time of maximum plasma concentration (Tmax) during up to 9 days of administration
Measured: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Area under the plasma concentration curve (AUC) during up to 9 days of administration
Measured: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
The fraction of drug excreted unchanged in urine (Fe) during up to 9 days of administration
Measured: Urine samples were collected 0 - 4 hr, 4 - 8 hr, 8 - 12 hr, 12 - 24 hr, 24 - 48 hr, 48 - 72 hr, 72 - 96 hr after administration at Day 1 and Day 9
Secondary outcomes (2)
Apparent clearance (CL/F)
Measured: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Apparent volume of distribution (V/F)
Measured: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2011 (estimated)
- Study startNov 2008
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 51 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
- NCT01450111
- Sponsor's protocol ID
- SP0952
- Status last verified
- Oct 2011
- First submitted
- 7 Oct 2011
- Last updated
- 14 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-site, Randomized, Double-blind, Placebo-controlled, Parallel-group, Single/Repeated Dose Trial to Evaluate the Pharmacokinetics and Safety/Tolerability of Lacosamide in 3 Dosages in Healthy Male Korean Subjects
- ClinicalTrials.gov ID
- NCT01450111
- Acronym / sponsor ID
- SP0952
- Conditions
- Epilepsy
- Keywords
- Lacosamide
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- UCB PharmaIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 12 Oct 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.
Primary objective of this trial was to investigate the pharmacokinetics of single dose and repeated dose applications of lacosamide in healthy male Korean subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Lacosamide 50 mg group | Experimental | Drug: LacosamideLacosamide 50 mg tablet, once a day per os (po) |
| Placebo group matched with lacosamide 50 mg | Placebo comparator | Other: PlaceboPlacebo matched with lacosamide 50 mg tablet, po |
| Lacosamide 100 mg group | Experimental | Drug: LacosamideLacosamide 100 mg tablet, po |
| Placebo group matched with lacosamide 100 mg | Placebo comparator | Other: PlaceboPlacebo matched with lacosamide 100 mg tablet, po |
| Lacosamide 200 mg group | Experimental | Drug: LacosamideLacosamide 200 mg tablet, po |
| Placebo group matched with lacosamide 200 mg | Placebo comparator | Other: PlaceboPlacebo matched with lacosamide 200 mg tablet, po |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Subject is healthy male and between 20 and 45 years of age (inclusive)
- Subject has no clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities and is in general good health
- Subject is of normal body weight as determined by a body mass index (BMI) between 19 and 28 kgm^2
- Subject is Korean (both parents are of pure Korean ethnicity)
Key exclusion criteria (25 listed)
- Subject has a history of or present psychiatric or neurological condition that, in the opinion of the Investigator, could jeopardize or would have compromised the subject's ability to participate in this trial
- Subject has a known or suspected drug hypersensitivity, in particular to the trial medication
- Subject consumes more than 40 g alcohol/day (amount corresponds to 1 L beer/day or 0.5 L wine/day or 6 glasses (à 2cL) liquor/day)
- Subject has donated blood or had a comparable blood loss (>400 mL) within the last 3 months prior to Eligibility Assessment (EA)
- Subject smokes more than 5 cigarettes per day or had done so within 6 months prior to EA.
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®Lacosamide 50 mg, tablet, once in the morning on Day 1 | Drug | Lacosamide 50 mg group |
| LacosamideAlso: Vimpat®Lacosamide 100 mg, tablet, once in the morning on Day 1 Lacosamide 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 | Drug | Lacosamide 100 mg group |
| LacosamideAlso: Vimpat®Lacosamide 200 mg, tablet, once in the morning on Day 1 Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 | Drug | Lacosamide 200 mg group |
| PlaceboPlacebo matched with Lacosamide 50 mg tablet once in the morning on day 1. | Other | Placebo group matched with lacosamide 50 mg |
| PlaceboPlacebo matched with Lacosamide 100 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamode 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 | Other | Placebo group matched with lacosamide 100 mg |
| PlaceboPlacebo matched with Lacosamide 200 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9 | Other | Placebo group matched with lacosamide 200 mg |
Primary outcome
Maximum concentration of lacosamide at steady state (Cmax) during up to 9 days of administration
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Time of maximum plasma concentration (Tmax) during up to 9 days of administration
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Area under the plasma concentration curve (AUC) during up to 9 days of administration
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
The fraction of drug excreted unchanged in urine (Fe) during up to 9 days of administration
Time frame: Urine samples were collected 0 - 4 hr, 4 - 8 hr, 8 - 12 hr, 12 - 24 hr, 24 - 48 hr, 48 - 72 hr, 72 - 96 hr after administration at Day 1 and Day 9
2 secondary outcomes
Apparent clearance (CL/F)
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
Apparent volume of distribution (V/F)
Time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)
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 14 Oct 2011.
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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)
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Lacosamide in people with Epilepsy, run by UCB Pharma.
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 4 inclusion and 25 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 14 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
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 concentration of lacosamide at steady state (Cmax) during up to 9 days of administration (time frame: Pharmacokinetic samples were taken pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84 and 96 hours after the first administration (at Day 1 & Day 9) and immediately before all administrations (at Day 5~8)). The study lists 4 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 14 Oct 2011.