- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01796938
Study to Evaluate the Pharmacokinetics, Safety, Tolerability of Single Dose Lacosamide in Subjects With Renal Impairment Compared to Healthy Subjects
perjantai 17. lokakuuta 2014 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Opintotyyppi
Interventio
Ilmoittautuminen (Todellinen)
40
Vaihe
- Vaihe 1
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Cologne, Saksa
- 1
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Rendsburg, Saksa
- 2
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
18 vuotta - 70 vuotta (Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Joo
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Kokeellinen: Group 1: Healthy subjects
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Muut nimet:
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Kokeellinen: Group 2: Subjects with mild renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Muut nimet:
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Kokeellinen: Group 3: Subjects with moderate renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Muut nimet:
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Kokeellinen: Group 4: Subjects with severe renal insufficiency
Single dose of 100 mg Lacosamide
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Single dose of 100 mg Lacosamide tablet
Muut nimet:
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Kokeellinen: 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
Muut nimet:
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Area under the Lacosamide plasma concentration time curve from 0 to the last quantifiable data point (AUC(0-tz))
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Time of observed maximum (tmax) of Lacosamide concentration
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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))
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
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Opintojen ennätyspäivät
Nämä päivämäärät seuraavat ClinicalTrials.gov-sivustolle lähetettyjen tutkimustietueiden ja yhteenvetojen edistymistä. National Library of Medicine (NLM) tarkistaa tutkimustiedot ja raportoidut tulokset varmistaakseen, että ne täyttävät tietyt laadunvalvontastandardit, ennen kuin ne julkaistaan julkisella verkkosivustolla.
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Tiistai 1. kesäkuuta 2004
Ensisijainen valmistuminen (Todellinen)
Maanantai 1. marraskuuta 2004
Opintojen valmistuminen (Todellinen)
Maanantai 1. marraskuuta 2004
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Tiistai 19. helmikuuta 2013
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Torstai 21. helmikuuta 2013
Ensimmäinen Lähetetty (Arvio)
Perjantai 22. helmikuuta 2013
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Maanantai 20. lokakuuta 2014
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Perjantai 17. lokakuuta 2014
Viimeksi vahvistettu
Perjantai 1. helmikuuta 2013
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- SP0641
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Kliiniset tutkimukset Lacosamide tablet
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University Hospital, Basel, SwitzerlandSwiss National Science FoundationRekrytointiTartunnan jälkeinen yskäSveitsi