- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01796938
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
17 ottobre 2014 aggiornato da: 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.
Panoramica dello studio
Stato
Completato
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Effettivo)
40
Fase
- Fase 1
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
-
-
Cologne, Germania
- 1
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Rendsburg, Germania
- 2
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 18 anni a 70 anni (Adulto, Adulto più anziano)
Accetta volontari sani
Sì
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: Group 1: Healthy subjects
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Altri nomi:
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Sperimentale: Group 2: Subjects with mild renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Altri nomi:
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Sperimentale: Group 3: Subjects with moderate renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Altri nomi:
|
Sperimentale: Group 4: Subjects with severe renal insufficiency
Single dose of 100 mg Lacosamide
|
Single dose of 100 mg Lacosamide tablet
Altri nomi:
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Sperimentale: 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
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz))
Lasso di tempo: 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
Lasso di tempo: 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
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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
Lasso di tempo: 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
|
Day 1 to Day 5 of study
|
Measured maximal concentration (Cmax, norm) of Lacosamide normalized by body weight
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Time of observed maximum (tmax) of Lacosamide concentration
Lasso di tempo: 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
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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
Lasso di tempo: 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
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Terminal half-life (t1/2) of Lacosamide
Lasso di tempo: 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)
Lasso di tempo: 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
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Apparent total clearance (CL/f) of Lacosamide from plasma
Lasso di tempo: 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))
Lasso di tempo: 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
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Amount of Lacosamide excreted in urine from 0 to defined time point (Ae(0-48)) (t=48 hours)
Lasso di tempo: 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)
Lasso di tempo: 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
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Measured maximal concentration (Cmax) of Lacosamide metabolite (SPM12809)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 giugno 2004
Completamento primario (Effettivo)
1 novembre 2004
Completamento dello studio (Effettivo)
1 novembre 2004
Date di iscrizione allo studio
Primo inviato
19 febbraio 2013
Primo inviato che soddisfa i criteri di controllo qualità
21 febbraio 2013
Primo Inserito (Stima)
22 febbraio 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
20 ottobre 2014
Ultimo aggiornamento inviato che soddisfa i criteri QC
17 ottobre 2014
Ultimo verificato
1 febbraio 2013
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- SP0641
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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