Study of the Pharmacokinetics and Safety of Asunaprevir in Patients With Kidney Disease
8 november 2013 uppdaterad av: Bristol-Myers Squibb
Open-Label, Parallel Group, Multiple-Dose Study to Evaluate the Pharmacokinetics and Safety of Asunaprevir in Subjects With Renal Function Impairment
The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Studieöversikt
Detaljerad beskrivning
Primary Purpose:
Other: The purpose of the study is to determine how Asunaprevir is handled by the body of subjects with kidney disease compared with subjects with normal kidney function
Studietyp
Interventionell
Inskrivning (Faktisk)
48
Fas
- Fas 1
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Florida
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Orlando, Florida, Förenta staterna, 32809
- Orlando Clinical Research Center
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55404
- DaVita Clinical Research
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Tennessee
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Knoxville, Tennessee, Förenta staterna, 37920
- New Orleans Center for Clinical Research
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Group A: Subjects with normal renal function
- Group B: Patients with end stage renal disease
- Group C: Patients with mild renal impairment
- Group D: Patients with moderate renal impairment
- Group E: Patients with severe renal impairment
Exclusion Criteria:
- History of uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, psychiatric and/or neurological disease
- Hepatitis B or C
- Human Immunodeficiency Virus (HIV)
- Recent gastrointestinal disease
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: Arm A: Subjects with normal renal function
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
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Andra namn:
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Experimentell: Arm B: Subjects with end stage renal disease
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
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Andra namn:
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Experimentell: Arm C: Subjects with mild renal impairment
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
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Andra namn:
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Experimentell: Arm D: Subjects with moderate renal impairment
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
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Andra namn:
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Experimentell: Arm E: Subjects with severe renal impairment
Asunaprevir 100 mg tablet by mouth twice daily for 7 days
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Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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AUC(TAU) of Asunaprevir assessed using plasma concentrations on Day 7
Tidsram: 11 time points on Day 7
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Area under the concentration-time curve in one dosing interval [AUC(TAU)] will be calculated from the blood drug concentration versus time curve
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11 time points on Day 7
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Plasma protein binding (PB) of Asunaprevir will be determined from the 1 hour and 3 hour time points post-dose
Tidsram: 1 and 3 hours of Day 7
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1 and 3 hours of Day 7
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Maximum observed plasma concentration (Cmax) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Pharmacokinetic (PK) parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Unbound Maximum observed plasma concentrations (Cmaxu) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Time of maximum observed plasma concentration (Tmax) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Minimum observed plasma concentration at one dose interval (C12) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Minimum observed plasma concentration at Pre-AM dose (Ctrough) of Asunaprevir
Tidsram: 3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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3 time points up to Day 7 (blood) and 2 time points on Days 1 and 7 (urine)
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Unbound area under the concentration-time curve in one dosing interval [AUC(TAU)u] of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
|
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Area under the concentration-time curve till time of last sampling [AUC(0-T)] of Asunaprevir
Tidsram: 11 (blood) and 2 (urine) time points on Day 7
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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11 (blood) and 2 (urine) time points on Day 7
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Terminal elimination half life (T-Half) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Percent urinary recovery (%UR) of Asunaprevir
Tidsram: 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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3 time points up to Day 7 (urine)
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Apparent total body clearance (CLT/F) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Unbound apparent clearance (CLU/F) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Renal clearance (CLR) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Apparent volume of distribution (Vd/F) of Asunaprevir
Tidsram: 30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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30 time points up to Day 10 (blood) and 3 time points up to Day 7 (urine)
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Accumulation index (AI): Ratio of AUC(TAU) on Day 7 to AUC(TAU) on Day 1
Tidsram: 22 (blood) and 3 (urine) time points on Days 1 and 7
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PK parameters will be derived from plasma concentration versus time and urinary excretion data (not applicable for subjects who are anuric)
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22 (blood) and 3 (urine) time points on Days 1 and 7
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Safety and tolerability endpoints include all AEs and serious AEs, clinical laboratory tests, ECGs, vital signs and physical examination results
Tidsram: Up to Day 15 and until 30 days post discontinuation of dosing
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All recorded adverse events (AEs) will be listed and tabulated by system organ class, preferred term and renal function group.
Vital signs and clinical laboratory test results will be listed and summarized by renal function group and time.
Any significant physical examination findings and clinical laboratory results will be listed.
Electrocardiogram (ECG) readings will be evaluated by the investigator and abnormalities, if present, will be listed
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Up to Day 15 and until 30 days post discontinuation of dosing
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 november 2012
Primärt slutförande (Faktisk)
1 februari 2013
Avslutad studie (Faktisk)
1 februari 2013
Studieregistreringsdatum
Först inskickad
24 juni 2013
Först inskickad som uppfyllde QC-kriterierna
24 juni 2013
Första postat (Uppskatta)
26 juni 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
11 november 2013
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
8 november 2013
Senast verifierad
1 november 2013
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- AI447-033
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