- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT00859053
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
9 september 2015 bijgewerkt door: Bristol-Myers Squibb
Single-Dose Pharmacokinetics of BMS-790052 in Subjects With Hepatic Impairment Compared to Healthy Subjects
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
Studie Overzicht
Studietype
Ingrijpend
Inschrijving (Werkelijk)
46
Fase
- Fase 1
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
California
-
Anaheim, California, Verenigde Staten, 92801
- Advanced Clinical Research Institute
-
-
Florida
-
Orlando, Florida, Verenigde Staten, 32809
- Orlando Clinical Research Center
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar tot 70 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Ja
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
Key Inclusion Criteria:
- Male and female subjects aged 18 to 70 years, with hepatic impairment conforming to Child-Pugh class A, B or C
- Healthy subjects to the extent possible matched to the first four hepatically impaired subject in each Child-Pugh class with regard to age (approximately ± 10 years), body weight (approximately ± 20%) and gender
Key Exclusion Criteria:
- History of esophageal and gastric variceal bleeding within past 6 months
- Primarily cholestatic liver diseases
- Active alcoholic hepatitis
- Stable encephalopathy of >= Stage 2
- Presence of severe ascites or edema
- Presence of hepatopulmonary or hepatorenal syndrome
- Positive for HCV, unless HCV RNA is undetectable
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Actieve vergelijker: BMS-790052 in Child-Pugh A
|
Capsules, Oral, 30 mg, single dose, one day
|
Actieve vergelijker: BMS-790052 in Child-Pugh B
|
Capsules, Oral, 30 mg, single dose, one day
|
Actieve vergelijker: BMS-790052 in Child-Pugh C
|
Capsules, Oral, 30 mg, single dose, one day
|
Actieve vergelijker: BMS-790052 in Healthy Subjects
|
Capsules, Oral, 30 mg, single dose, one day
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Maximum Observed Plasma Concentration (Cmax) of BMS-790052
Tijdsspanne: Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Maximum observed plasma concentration following drug administration from the raw plasma concentration-time data.
The plasma samples were analysed for BMS-790052 by using a validated liquid chromatography tandem mass spectrometric (LC-MS/MS) assay.
|
Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052
Tijdsspanne: Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
AUC(0-T) was calculated by the sum of linear trapezoids using non-compartmental analysis.
|
Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052
Tijdsspanne: Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.
|
Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052
Tijdsspanne: Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Tmax was defined as the time required to reach maximum observed plasma concentration.
Tmax was directly determined from the raw plasma concentration-time data.
|
Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Terminal Half-life (T-HALF) of BMS-790052
Tijdsspanne: Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Terminal half-life was the time required for one half of the total amount of administered drug eliminated from the body.
|
Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Apparent Total Body Clearance (CLT/F) of BMS-790052
Tijdsspanne: Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Apparent total body clearance was calculated as dose/AUC(INF).
AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.
|
Pre-dose (0), 0.5,1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Apparent Clearance of Free BMS-790052 (CLu/F)
Tijdsspanne: Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
CLu/F was calculated by dividing the apparent total body clearance (CLT/F) by mean fraction of unbound drug (fu) for both (1 hour and 4 hour post dose) time points combined.
Apparent total body clearance was calculated as dose/AUC(INF).
AUC(INF) was estimated as AUC(0-T) + Ct/ λz, where λz was the terminal elimination rate constant and Ct was the last observable concentration.
|
Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
The Apparent Volume of Distribution at Steady State (Vss/F)
Tijdsspanne: Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Apparent volume of distribution was calculated by dividing the product of the dose and mean residence time (MRT) by AUC(INF).
AUC(INF) was estimated as AUC(0-T) + Ct/λ z, where λ z was the terminal elimination rate constant and Ct was the last observable concentration.
|
Pre-dose (0), 0.5, 1, 1.5, 2, 4, 8, 12, 24, 48, 72 hours post-dose (both healthy and hepatically impaired participants) and 96 hours post-dose (only for hepatically impaired participants)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
Tijdsspanne: Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.
|
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a pre-existing condition that does not necessarily have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Study Discharge (end of study) was Day 4 (healthy participants) or Day 5 (hepatically impaired participants).
|
Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2009
Primaire voltooiing (Werkelijk)
1 september 2009
Studie voltooiing (Werkelijk)
1 september 2009
Studieregistratiedata
Eerst ingediend
6 maart 2009
Eerst ingediend dat voldeed aan de QC-criteria
9 maart 2009
Eerst geplaatst (Schatting)
10 maart 2009
Updates van studierecords
Laatste update geplaatst (Schatting)
8 oktober 2015
Laatste update ingediend die voldeed aan QC-criteria
9 september 2015
Laatst geverifieerd
1 september 2015
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- AI444-013
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op BMS-790052
-
Bristol-Myers SquibbNiet meer beschikbaar
-
Bristol-Myers SquibbVoltooidHepatitis CFrankrijk, Duitsland, Italië, Japan, Verenigde Staten, Australië, Puerto Rico, Spanje, Nieuw-Zeeland
-
Bristol-Myers SquibbIngetrokkenHepatitis C-virusVerenigde Staten
-
Bristol-Myers SquibbVoltooid
-
Bristol-Myers SquibbVoltooidHepatitis CVerenigde Staten
-
Bristol-Myers SquibbVoltooid
-
Bristol-Myers SquibbVoltooid
-
Bristol-Myers SquibbVoltooidHepatitis CChina, Korea, republiek van, Taiwan
-
Bristol-Myers SquibbVoltooidHepatitis CVerenigde Staten, Australië, Canada, Frankrijk
-
Tarek I. Hassanein, M.D., FACP, FAG, AGAFVoltooidHepatitis C | CirroseVerenigde Staten