- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01796938
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
17 de octubre de 2014 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Actual)
40
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Cologne, Alemania
- 1
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Rendsburg, Alemania
- 2
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Group 1: Healthy subjects
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Otros nombres:
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Experimental: Group 2: Subjects with mild renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Otros nombres:
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Experimental: Group 3: Subjects with moderate renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Otros nombres:
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Experimental: Group 4: Subjects with severe renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Otros nombres:
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Experimental: Group 5: Subjects with end stage renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz))
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Measured maximal concentration (Cmax) of Lacosamide
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Area under the Lacosamide plasma concentration-time curve from 0 to the last quantifiable data point (AUC (0-tz)), normalized by body weight
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Measured maximal concentration (Cmax, norm) of Lacosamide normalized by body weight
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Time of observed maximum (tmax) of Lacosamide concentration
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Time of observed maximum (tmax) of Lacosamide metabolite (SPM12809) concentration
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Terminal half-life (t1/2) of Lacosamide
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Terminal half-life (t1/2) of Lacosamide metabolite (SPM12809)
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Apparent total clearance (CL/f) of Lacosamide from plasma
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Area under the lacosamide metabolite (SPM12809) plasma concentration-time curve from 0 to the last quantifiable data point (AUC(0-tz))
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Amount of Lacosamide excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Periodo de tiempo: Day 1 to Day 3 of study
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Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
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Day 1 to Day 3 of study
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Amount of Lacosamide metabolite (SPM12809) excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Periodo de tiempo: Day 1 to Day 3 of study
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Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
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Day 1 to Day 3 of study
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Measured maximal concentration (Cmax) of Lacosamide metabolite (SPM12809)
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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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
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Measured maximal Lacosamide metabolite (SPM12809) concentration (Cmax,norm), normalized by body weight
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Terminal half-life (t1/2) of Lacosamide in urine
Periodo de tiempo: Day 1 to Day 3 of study
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Urine sampling predose, 0-4, 4-8, 8-12, 12-24, 24-36, and 36-48 hours postdose
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Day 1 to Day 3 of study
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Lacosamide concentration in dialysis inlet line (Cin)
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Lacosamide metabolite (SPM12809) concentration in dialysis inlet line (Cin)
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Lacosamide concentration in dialysis outlet line (Cout)
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Lacosamide metabolite (SPM12809) concentration in dialysis outlet line (Cout)
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Extraction rate (E) of Lacosamide
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Extraction rate (E) of Lacosamide metabolite (SPM12809)
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Dialysis clearance (CLdial) of Lacosamide
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Dialysis clearance (CLdial) of Lacosamide metabolite (SPM12809)
Periodo de tiempo: From 4 hours up to 6 hours postdose
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Dialysis samples collected 4 hours and 6 hours after administration (1.5 hours and 3.5 hours after start of dialysis)
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From 4 hours up to 6 hours postdose
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Rate constant of Lacosamide elimination
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Rate constant of Lacosamide metabolite (SPM12809) elimination
Periodo de tiempo: Day 1 to Day 5 of study
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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
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Day 1 to Day 5 of study
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2004
Finalización primaria (Actual)
1 de noviembre de 2004
Finalización del estudio (Actual)
1 de noviembre de 2004
Fechas de registro del estudio
Enviado por primera vez
19 de febrero de 2013
Primero enviado que cumplió con los criterios de control de calidad
21 de febrero de 2013
Publicado por primera vez (Estimar)
22 de febrero de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
20 de octubre de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
17 de octubre de 2014
Última verificación
1 de febrero de 2013
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SP0641
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Lacosamide tablet
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University Hospital, Clermont-FerrandDr Gisèle PICKERING (MCU-PH)(Clinical Pharmacology center, Inserm 501); Dr Gilles...Terminado
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Kowa Research Institute, Inc.Terminado
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The University of Hong KongReclutamientoEnvejecer bienHong Kong
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Giovanni CioniAzienda USL Toscana Nord Ovest; Scuola Superiore Sant'Anna di PisaReclutamientoDiscapacidades del desarrollo congénitas y adquiridasItalia
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Shinshu UniversityReclutamiento
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Hannover Medical SchoolDesconocidoInmunosupresores después del trasplante de pulmónAlemania
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Hevert-Arzneimittel GmbH & Co. KGTerminado
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Kremers Urban Development CompanyWatson Laboratories, Inc.Terminado
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Bright Future Pharmaceuticals Factory O/B Bright...Chinese University of Hong KongTerminado