HealthyPhase 1NCT01796938

Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects

A Phase 1 study testing Lacosamide tablet in people with Healthy and Renal Impairment, run by UCB BIOSCIENCES GmbH at 2 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects. Read more about this study

Who is it for?: Ages 18 to 70 yearsHealthy volunteers can take part
Conditions the study is for: Healthy, Renal Impairment
What is being tested?: Lacosamide tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 2 sitesGermany
Study dates: Jun 2004to Nov 2004
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 70 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subject was informed and given ample time and opportunity to think about his/her participation and had given his/her written informed consent
Subject was willing and able to comply with all trial requirements
Subject was a male or female Caucasian, between 18 and 70 years of age (inclusive)
If female, subject was of non-childbearing potential (post-menopausal or hysterectomized) or was using medically adequate contraception
If female of childbearing potential, subject had a negative pregnancy test
Subject had a Body Mass Index (BMI) between 20 and 34 kg/m2 (inclusive)

Show all 21Show fewer

Subject was healthy without clinically relevant cardiovascular, renal, gastrointestinal, hepatic, metabolic, endocrine, neurological, or psychiatric abnormalities detected during Eligibility Assessment (EA)
Subjects with renal impairment also had to fulfill the following inclusion criteria:
Subject had no clinically relevant cardiovascular or endocrine findings during EA
Subject had a renal impairment. The subjects were assigned to 1 of the following treatment groups according to Creatinine Clearance (CLCr) values determined 2 to 7 days prior to dosing:
Group 2: 80 mL/min > CLCr ≥ 50 mL/min (subjects with mild renal impairment)
Group 3: 50 mL/min > CLCr ≥ 30 mL/min (subjects with moderate renal impairment)
Group 4: CLCr < 30 mL/min (subjects with severe renal impairment, not on dialysis between 2 weeks before EA and end of the trial)
Subject was informed and given ample time and opportunity to think about his/her participation and had given his/her written informed consent
Subject was willing and able to comply with all trial requirements
Subject was a male or female Caucasian, between 18 and 70 years of age (inclusive)
If female, subject was of non-childbearing potential (post-menopausal or hysterectomized) or was using medically adequate contraception
If female of childbearing potential, subject had a negative pregnancy test
Subject had a BMI between 20 and 34 kg/m2 (inclusive)
Subject had no clinically relevant cardiovascular or endocrine findings during EA
Subject had an endstage renal disease (CLCr < 15 mL/min, determined approximately 2 to 7 days before first dosing) treated with extracorporal hemodialysis for at least 4 months

Who cannot join

Healthy subjects:
Subject had previously participated in this trial
Subject had participated in another trial of an investigational product within the last 3 months or was currently participating in another trial of an investigational product
Subject had donated blood or had a comparable blood loss (> 500 mL) within the last 3 months prior to EA
Subject smoked more than 5 cigarettes per day or had done so within the 6 months prior to commencement of this trial
Subject had a history of chronic alcohol or drug abuse within the last 6 months prior to commencement of this trial

Show all 35Show fewer

Subject consumed more than 40 g of alcohol/day (amount corresponds to 1 L beer/day or 0.5 L wine/day or 120 mL liquor/day)
Subject had positive tests for alcohol (urine or breath test) or drugs (urine test)
Subject had clinically relevant changes in the electrocardiogram (ECG), such as second- or third-degree atrioventricular (AV) block, prolongation of the QRS complex over 120 ms or of the corrected QT (QTc) interval > 430 ms (male subjects) or > 450 ms (female subjects)
Subject had a history or present condition of clinically relevant respiratory or cardiovascular disorders, eg, cardiac insufficiency, coronary heart disease, hypertension, arrhythmia, tachyarrhythmia, or status after myocardial infarction
Subject had a history or present condition of psychic abnormality, psychiatric or neurologic illness, or autonomic neuropathy that, in the opinion of the Investigator, could have jeopardized or would have compromised the subject's ability to participate in the trial
Subject had a history or present condition of seizure disorder
Subject had a history or present condition of malignancy
Subject had a history or present condition of renal disorders (albuminuria, chronic infections) or renal impairment
Subject had a history or present condition of Diabetes Mellitus or thyroid dysfunction, especially Hyperthyreosis, or other endocrine disorders
Subject had a clinically relevant allergy
Subject had a known or suspected drug hypersensitivity, in particular to the trial medication
Subject was taking any concomitant medication currently or within 2 weeks prior to the first day of dosing (with the exception of oral contraceptives and Paracetamol [maximum allowed dose: 1000 mg/dose], which were allowed up to 48 hours prior to dosing); further exceptions could be made if the Investigator and the sponsor jointly considered the medication as acceptable
Subject was tested positive for human immunodeficiency virus 1/2 antibodies (HIV-1/2-Ab), hepatitis B surface antigen (HBs-Ag), or hepatitis C virus antibody (HCV-Ab)
Subject had any clinically relevant abnormality in the physical examination or in vital sign measurements (systolic blood pressure > 150 mmHg or < 100 mmHg, diastolic blood pressure > 95 mmHg or < 60 mmHg, pulse rate > 100 beats per minute (bpm) or < 50 bpm)
Subject had a clinically relevant deviation from the norm in the clinical chemistry, hematology, or urinalysis evaluations
Exclusion criteria 1 to 12 for healthy subjects also applied to subjects with renal impairment
Subject had a clinically relevant allergy
Subject had a known or suspected drug hypersensitivity, in particular to the trial medication
Subject was taking any concomitant medication currently or within 2 weeks prior to dosing that could have interfered with the investigational product
Subject was tested positive for HIV-1/2-Ab, HBs-Ag, or HCV-Ab
Subject had any clinically relevant abnormality in the physical examination or in vital sign measurements (systolic blood pressure > 180 mmHg or < 100 mmHg, diastolic blood pressure > 110 mmHg, pulse rate > 100 bpm or < 60 bpm)
Subject had a clinically relevant deviation from the norm in the clinical chemistry, hematology or urinalysis evaluations other than expected for a subject with renal impairment, eg, hemoglobin < 8.0 g/dL
Exclusion criteria 1 to 12 for healthy subjects also applied to subjects in Group 5
Subject had a clinically relevant allergy
Subject had a known or suspected drug hypersensitivity, in particular to the trial medication
Subject was tested positive for HIV-1/2-Ab, HBs-Ag, or HCV-Ab
Subject was taking any concomitant medication that might interfere with the investigational product currently or within 2 weeks prior to dosing
Subject had any clinically relevant abnormality in the physical examination or in vital sign measurements (systolic blood pressure > 200 mmHg [predialysis value] or < 100 mmHg, diastolic blood pressure > 110 mmHg, pulse rate > 100 bpm or < 60 bpm)
Subject had a clinically relevant deviation from the norm in the clinical chemistry, hematology, or urinalysis evaluations other than expected for a patient with renal impairment, eg, hemoglobin < 8.0 g/dL

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

1
Cologne
2
Rendsburg

Other trials in Germany

About this study

Official title: Open, Non-randomized, Sequential Group Comparison to Investigate the Pharmacokinetics, Safety, and Tolerability of 100 mg SPM 927 in Male and Female Subjects With Renal Impairment Including Subjects Requiring Dialysis Compared With Male and Female Healthy Subjects Following Single-dose Administration

To investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.

Conditions: Healthy, Renal Impairment
Being tested: Lacosamide tablet
Keywords: Lacosamide, Vimpat, Single Dose, Pharmacokinetics, Renal Impairment
Medical subject headings: Renal Insufficiency

What participants receive

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

Lacosamide tabletDrug
Also called Vimpat
Single dose of 100 mg Lacosamide tablet

Study groups in NCT01796938
Study group	Role	What they receive
Group 1: Healthy subjects	Experimental	Single dose of 100 mg Lacosamide Receives: Drug: Lacosamide tablet
Group 2: Subjects with mild renal insufficiency	Experimental	Single dose of 100 mg Lacosamide Receives: Drug: Lacosamide tablet
Group 3: Subjects with moderate renal insufficiency	Experimental	Single dose of 100 mg Lacosamide Receives: Drug: Lacosamide tablet
Group 4: Subjects with severe renal insufficiency	Experimental	Single dose of 100 mg Lacosamide Receives: Drug: Lacosamide tablet
Group 5: Subjects with end stage renal insufficiency	Experimental	Single dose of 100 mg Lacosamide Receives: Drug: Lacosamide tablet

What is being measured

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

Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz))
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Measured maximal concentration (Cmax) of Lacosamide
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Area under the Lacosamide plasma concentration-time curve from 0 to the last quantifiable data point (AUC (0-tz)), normalized by body weight
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Measured maximal concentration (Cmax, norm) of Lacosamide normalized by body weight
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study

Secondary outcomes (22)

Time of observed maximum (tmax) of Lacosamide concentration
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Time of observed maximum (tmax) of Lacosamide metabolite (SPM12809) concentration
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Terminal half-life (t1/2) of Lacosamide
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Terminal half-life (t1/2) of Lacosamide metabolite (SPM12809)
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Apparent total clearance (CL/f) of Lacosamide from plasma
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Area under the lacosamide metabolite (SPM12809) plasma concentration-time curve from 0 to the last quantifiable data point (AUC(0-tz))
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Amount of Lacosamide excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
Measured: Day 1 to Day 3 of study
Amount of Lacosamide metabolite (SPM12809) excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
Measured: Day 1 to Day 3 of study
Measured maximal concentration (Cmax) of Lacosamide metabolite (SPM12809)
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Area under the Lacosamide metabolite (SPM12809) plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz)), normalized by body weight
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Measured maximal Lacosamide metabolite (SPM12809) concentration (Cmax,norm), normalized by body weight
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Terminal half-life (t1/2) of Lacosamide in urine
Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
Measured: Day 1 to Day 3 of study
Lacosamide concentration in dialysis inlet line (Cin)
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Lacosamide metabolite (SPM12809) concentration in dialysis inlet line (Cin)
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Lacosamide concentration in dialysis outlet line (Cout)
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Lacosamide metabolite (SPM12809) concentration in dialysis outlet line (Cout)
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Extraction rate (E) of Lacosamide
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Extraction rate (E) of Lacosamide metabolite (SPM12809)
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Dialysis clearance (CLdial) of Lacosamide
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Dialysis clearance (CLdial) of Lacosamide metabolite (SPM12809)
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
Measured: From 4 hours up to 6 hours postdose
Rate constant of Lacosamide elimination
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study
Rate constant of Lacosamide metabolite (SPM12809) elimination
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured: Day 1 to Day 5 of study

Timeline

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

Jun 2004Nov 2004

First posted22 Feb 2013 (estimated)
Study startJun 2004
Primary completionNov 2004
Study completionNov 2004

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for HealthyStudies 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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01796938
Sponsor's protocol ID: SP0641
Status last verified: Feb 2013
First submitted: 19 Feb 2013
Last updated: 20 Oct 2014
Results posted: No
Data monitoring committee: No

Publications

Cawello W, Fuhr U, Hering U, Maatouk H, Halabi A. Impact of impaired renal function on the pharmacokinetics of the antiepileptic drug lacosamide. Clin Pharmacokinet. 2013 Oct;52(10):897-906. doi: 10.1007/s40262-013-0080-7.
PubMed 23737404

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 20 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open, Non-randomized, Sequential Group Comparison to Investigate the Pharmacokinetics, Safety, and Tolerability of 100 mg SPM 927 in Male and Female Subjects With Renal Impairment Including Subjects Requiring Dialysis Compared With Male and Female Healthy Subjects Following Single-dose Administration
ClinicalTrials.gov ID: NCT01796938
Acronym / sponsor ID: SP0641
Conditions: Healthy, Renal Impairment
Keywords: Lacosamide, Vimpat, Single Dose, Pharmacokinetics, Renal Impairment
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: UCB BIOSCIENCES GmbHIndustry (pharma, biotech, devices)
Study start: Jun 2004
Primary completion: Nov 2004 (actual)
Study completion: Nov 2004 (actual)
First posted: 22 Feb 2013 (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 investigate the Pharmacokinetics (PK) of oral administered Lacosamide in renal impaired subjects and healthy subjects.

Study design

Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 5

Arm	Type	Receives
Group 1: Healthy subjects	Experimental	Drug: Lacosamide tabletSingle dose of 100 mg Lacosamide
Group 2: Subjects with mild renal insufficiency	Experimental	Drug: Lacosamide tabletSingle dose of 100 mg Lacosamide
Group 3: Subjects with moderate renal insufficiency	Experimental	Drug: Lacosamide tabletSingle dose of 100 mg Lacosamide
Group 4: Subjects with severe renal insufficiency	Experimental	Drug: Lacosamide tabletSingle dose of 100 mg Lacosamide
Group 5: Subjects with end stage renal insufficiency	Experimental	Drug: Lacosamide tabletSingle dose of 100 mg Lacosamide

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (21 listed)

Subject was informed and given ample time and opportunity to think about his/her participation and had given his/her written informed consent
Subject was willing and able to comply with all trial requirements
Subject was a male or female Caucasian, between 18 and 70 years of age (inclusive)
If female, subject was of non-childbearing potential (post-menopausal or hysterectomized) or was using medically adequate contraception
If female of childbearing potential, subject had a negative pregnancy test

Key exclusion criteria (35 listed)

Subject had previously participated in this trial
Subject had participated in another trial of an investigational product within the last 3 months or was currently participating in another trial of an investigational product
Subject had donated blood or had a comparable blood loss (> 500 mL) within the last 3 months prior to EA
Subject smoked more than 5 cigarettes per day or had done so within the 6 months prior to commencement of this trial
Subject had a history of chronic alcohol or drug abuse within the last 6 months prior to commencement of this trial

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
Lacosamide tabletAlso: VimpatSingle dose of 100 mg Lacosamide tablet	Drug	Group 1: Healthy subjects, Group 2: Subjects with mild renal insufficiency, Group 3: Subjects with moderate renal insufficiency, Group 4: Subjects with severe renal insufficiency, Group 5: Subjects with end stage renal insufficiency

Primary outcome

Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz))
Time frame: Day 1 to Day 5 of study
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured maximal concentration (Cmax) of Lacosamide
Time frame: Day 1 to Day 5 of study
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Area under the Lacosamide plasma concentration-time curve from 0 to the last quantifiable data point (AUC (0-tz)), normalized by body weight
Time frame: Day 1 to Day 5 of study
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5
Measured maximal concentration (Cmax, norm) of Lacosamide normalized by body weight
Time frame: Day 1 to Day 5 of study
Blood sampling at 0 (predose), 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60, 72, 84, and 96 hours after single dose administration; > 24 hours excluded for group 5

22 secondary outcomes

Time of observed maximum (tmax) of Lacosamide concentration
Time frame: Day 1 to Day 5 of study
Time of observed maximum (tmax) of Lacosamide metabolite (SPM12809) concentration
Time frame: Day 1 to Day 5 of study
Terminal half-life (t1/2) of Lacosamide
Time frame: Day 1 to Day 5 of study
Terminal half-life (t1/2) of Lacosamide metabolite (SPM12809)
Time frame: Day 1 to Day 5 of study
Apparent total clearance (CL/f) of Lacosamide from plasma
Time frame: Day 1 to Day 5 of study
Area under the lacosamide metabolite (SPM12809) plasma concentration-time curve from 0 to the last quantifiable data point (AUC(0-tz))
Time frame: Day 1 to Day 5 of study
Amount of Lacosamide excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Time frame: Day 1 to Day 3 of study
Amount of Lacosamide metabolite (SPM12809) excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Time frame: Day 1 to Day 3 of study
Measured maximal concentration (Cmax) of Lacosamide metabolite (SPM12809)
Time frame: Day 1 to Day 5 of study
Area under the Lacosamide metabolite (SPM12809) plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz)), normalized by body weight
Time frame: Day 1 to Day 5 of study
Measured maximal Lacosamide metabolite (SPM12809) concentration (Cmax,norm), normalized by body weight
Time frame: Day 1 to Day 5 of study
Terminal half-life (t1/2) of Lacosamide in urine
Time frame: Day 1 to Day 3 of study
Lacosamide concentration in dialysis inlet line (Cin)
Time frame: From 4 hours up to 6 hours postdose
Lacosamide metabolite (SPM12809) concentration in dialysis inlet line (Cin)
Time frame: From 4 hours up to 6 hours postdose
Lacosamide concentration in dialysis outlet line (Cout)
Time frame: From 4 hours up to 6 hours postdose
Lacosamide metabolite (SPM12809) concentration in dialysis outlet line (Cout)
Time frame: From 4 hours up to 6 hours postdose
Extraction rate (E) of Lacosamide
Time frame: From 4 hours up to 6 hours postdose
Extraction rate (E) of Lacosamide metabolite (SPM12809)
Time frame: From 4 hours up to 6 hours postdose
Dialysis clearance (CLdial) of Lacosamide
Time frame: From 4 hours up to 6 hours postdose
Dialysis clearance (CLdial) of Lacosamide metabolite (SPM12809)
Time frame: From 4 hours up to 6 hours postdose
Rate constant of Lacosamide elimination
Time frame: Day 1 to Day 5 of study
Rate constant of Lacosamide metabolite (SPM12809) elimination
Time frame: Day 1 to Day 5 of study

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 20 Oct 2014.
Derived from this study: PubMed 23737404Cawello W, Fuhr U, Hering U, Maatouk H, Halabi A. Impact of impaired renal function on the pharmacokinetics of the antiepileptic drug lacosamide. Clin Pharmacokinet. 2013 Oct;52(10):897-906. doi: 10.1007/s40262-013-0080-7.

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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)

2 sites 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 tablet in people with Healthy and Renal Impairment, run by UCB BIOSCIENCES GmbH at 2 sites 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 21 inclusion and 35 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 20 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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. 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 Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz)) (time frame: Day 1 to Day 5 of study). 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?

On the ClinicalTrials.gov record for NCT01796938, which also lists 1 linked publication.

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 20 Oct 2014.