Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
9. september 2015 oppdatert av: 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.
Studieoversikt
Studietype
Intervensjonell
Registrering (Faktiske)
46
Fase
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Anaheim, California, Forente stater, 92801
- Advanced Clinical Research Institute
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Florida
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Orlando, Florida, Forente stater, 32809
- Orlando Clinical Research Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 70 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: BMS-790052 in Child-Pugh A
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Capsules, Oral, 30 mg, single dose, one day
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Aktiv komparator: BMS-790052 in Child-Pugh B
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Capsules, Oral, 30 mg, single dose, one day
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Aktiv komparator: BMS-790052 in Child-Pugh C
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Capsules, Oral, 30 mg, single dose, one day
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Aktiv komparator: BMS-790052 in Healthy Subjects
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Capsules, Oral, 30 mg, single dose, one day
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax) of BMS-790052
Tidsramme: 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.
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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)
|
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Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052
Tidsramme: 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.
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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)
|
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Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052
Tidsramme: 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)
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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.
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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)
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052
Tidsramme: 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.
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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)
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Terminal Half-life (T-HALF) of BMS-790052
Tidsramme: 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.
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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)
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Apparent Total Body Clearance (CLT/F) of BMS-790052
Tidsramme: 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)
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Apparent Clearance of Free BMS-790052 (CLu/F)
Tidsramme: 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)
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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.
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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)
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The Apparent Volume of Distribution at Steady State (Vss/F)
Tidsramme: 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)
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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.
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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)
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died
Tidsramme: Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.
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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).
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Day 1 to end of study for AEs and, Day 1 to up to 30 days after last dose for SAE.
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Samarbeidspartnere og etterforskere
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Sponsor
Studierekorddatoer
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Studer hoveddatoer
Studiestart
1. mars 2009
Primær fullføring (Faktiske)
1. september 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
6. mars 2009
Først innsendt som oppfylte QC-kriteriene
9. mars 2009
Først lagt ut (Anslag)
10. mars 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
8. oktober 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2015
Sist bekreftet
1. september 2015
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- AI444-013
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