- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01796938
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
October 17, 2014 updated by: UCB BIOSCIENCES GmbH
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cologne, Germany
- 1
-
Rendsburg, Germany
- 2
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
- 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)
Inclusion criteria for Group 5:
- 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
Exclusion Criteria:
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
- 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 for Groups 2-4:
- 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 for Group 5:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Group 1: Healthy subjects
Single dose of 100 mg Lacosamide
|
Single dose of 100 mg Lacosamide tablet
Other Names:
|
Experimental: Group 2: Subjects with mild renal insufficiency
Single dose of 100 mg Lacosamide
|
Single dose of 100 mg Lacosamide tablet
Other Names:
|
Experimental: Group 3: Subjects with moderate renal insufficiency
Single dose of 100 mg Lacosamide
|
Single dose of 100 mg Lacosamide tablet
Other Names:
|
Experimental: Group 4: Subjects with severe renal insufficiency
Single dose of 100 mg Lacosamide
|
Single dose of 100 mg Lacosamide tablet
Other Names:
|
Experimental: Group 5: Subjects with end stage renal insufficiency
Single dose of 100 mg Lacosamide
|
Single dose of 100 mg Lacosamide tablet
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Day 1 to Day 5 of study
|
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
|
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
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
|
Day 1 to Day 5 of study
|
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
|
Day 1 to Day 5 of study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of observed maximum (tmax) of Lacosamide concentration
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
|
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
|
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
|
Day 1 to Day 5 of study
|
Terminal half-life (t1/2) 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
|
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
|
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
|
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
|
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
|
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
|
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
|
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
|
Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
|
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
|
Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
|
Day 1 to Day 3 of study
|
Measured maximal concentration (Cmax) of Lacosamide metabolite (SPM12809)
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
|
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
|
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
|
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
|
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
|
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
|
Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
|
Day 1 to Day 3 of study
|
Lacosamide concentration in dialysis inlet line (Cin)
Time Frame: From 4 hours up to 6 hours postdose
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
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
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
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
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
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
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
From 4 hours up to 6 hours postdose
|
Extraction rate (E) of Lacosamide
Time Frame: From 4 hours up to 6 hours postdose
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
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 samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
From 4 hours up to 6 hours postdose
|
Dialysis clearance (CLdial) of Lacosamide
Time Frame: From 4 hours up to 6 hours postdose
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
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
|
Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
|
From 4 hours up to 6 hours postdose
|
Rate constant of Lacosamide elimination
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
|
Day 1 to Day 5 of study
|
Rate constant of Lacosamide metabolite (SPM12809) elimination
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
|
Day 1 to Day 5 of study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2004
Primary Completion (Actual)
November 1, 2004
Study Completion (Actual)
November 1, 2004
Study Registration Dates
First Submitted
February 19, 2013
First Submitted That Met QC Criteria
February 21, 2013
First Posted (Estimate)
February 22, 2013
Study Record Updates
Last Update Posted (Estimate)
October 20, 2014
Last Update Submitted That Met QC Criteria
October 17, 2014
Last Verified
February 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SP0641
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy
-
Prevent Age Resort "Pervaya Liniya"RecruitingHealthy Aging | Healthy Diet | Healthy LifestyleRussian Federation
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
Yale UniversityNot yet recruitingHealth-related Benefits of Introducing Table Olives Into the Diet of Young Adults: Olives For HealthHealthy Diet | Healthy Lifestyle | Healthy Nutrition | CholesterolUnited States
-
Hasselt UniversityRecruitingHealthy | Healthy AgingBelgium
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
University of PennsylvaniaActive, not recruitingHealthy | Healthy AgingUnited States
-
Chalmers University of TechnologyGöteborg UniversityCompletedHealthy | Nutrition, HealthySweden
-
University of ManitobaNot yet recruitingHealthy | Healthy Diet
-
King's College LondonUniversity of ReadingCompletedHealthy | Healthy AgingUnited Kingdom
Clinical Trials on Lacosamide tablet
-
UCB Biopharma S.P.R.L.Completed
-
UCB Biopharma S.P.R.L.CompletedHealthy VolunteersUnited Kingdom
-
UCB BIOSCIENCES, Inc.CompletedEpilepsyUnited States, Australia, Brazil, Bulgaria, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan
-
UCB Biopharma S.P.R.L.CompletedHealthy Male Chinese VolunteersChina
-
UCB BIOSCIENCES, Inc.Pharmaceutical Research AssociatesCompletedEpilepsyUnited States, Australia, Belgium, Brazil, Bulgaria, China, Czechia, France, Germany, Hungary, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Russian Federation, Slovakia, Spain, Taiwan
-
Laniado HospitalNot yet recruitingInfertility | IVFIsrael
-
Seoul National University HospitalDongsan Medical Center; Konkuk UniversityCompleted
-
University of California, San FranciscoSan Francisco VA Health Care SystemCompletedAlcohol Use DisorderUnited States
-
UCB PharmaCompleted
-
Overseas Pharmaceuticals, Ltd.Beijing Capton Pharmaceutical Technology Development Co., LTDNot yet recruiting