- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT02108639
To Assess the Effect of Renal Impairment on the Blood Levels of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325 After Multiple Doses of a Fixed Dose Combination Tablet
An Open-label, Multiple-dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of a Fixed Dose Combination Formulation of DCV, ASV, and BMS-791325 in Subjects With Normal Renal Function and Subjects With Mild, Moderate, Severe, and End-stage Renal Dysfunction
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
IND Number: 79,599/101,943
Primary Purpose: Other - Phase 1 Clinical Pharmacology study to determine the effect of renal impairment on the exposure of DCV, ASV, BMS-791325 (fixed dosed combination) and BMS-791325 given in multiple doses
Fixed dose combination (FDC)
Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325 (DCV 3DAA FDC)
Studietype
Registrering (Faktiske)
Fase
- Fase 1
Kontakter og plasseringer
Studiesteder
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Florida
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Miami, Florida, Forente stater, 33014
- Clinical Pharmacology Of Miami Inc.
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Orlando, Florida, Forente stater, 32809
- Orlando Clinical Research Center
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55404
- Davita Clinical Research
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Tennessee
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Knoxville, Tennessee, Forente stater, 37920
- New Orleans Center For Clinical Research - Knoxville
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Subjects in Group A must be in good health and have normal renal function
- Subjects in Groups B-E may have clinical, Electrocardiogram (ECG) and laboratory findings consistent with their degree of renal dysfunction
- Women of childbearing potential (WOCBP) and male participants must agree to follow the required contraceptive methods
Exclusion Criteria:
- Subjects in Group A must not have any significant acute or chronic illnesses
- Subjects in Groups B-E must not have uncontrolled or unstable cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematopoietic, and/or neurological disease within 6 months of screening
- Subjects in Groups B-E may not have evidence of rapidly deteriorating renal function, defined as a screening creatinine clearance (CLcr) which has decreased from a previous CLcr by 50% within the last 3 months
- Prior exposure to DCV, ASV or BMS-791325 within 3 months prior to study drug administration
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: DCV 3DAA FDC + BMS-791325
Group A to D: DCV 3DAA FDC + BMS-791325 oral tablets on specific days Group E: DCV 3DAA FDC + BMS-791325 oral tablets on specific days |
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Maximum observed plasma concentration (Cmax) for DCV, ASV, BMS-791325 and BMS-794712
Tidsramme: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
|
For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
|
Area under the concentration-time curve in 1 dosing interval (AUC(TAU)) for DCV, ASV, BMS-791325 and BMS-794712
Tidsramme: For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
|
For Groups A-D: Day 1 to Day 10 and for Group E: Day 1 to Day 12
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Concentration at 12 hours (C12) for (DCV, ASV, BMS-791325) and BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
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Time of maximum observed concentration (Tmax) for (DCV, ASV, BMS-791325) and BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Apparent total body clearance (CLT/F) for (DCV, ASV and BMS-791325 only)
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Trough observed plasma concentration (Ctrough) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Cmax fraction unbound (Cmaxfu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
BMS-948158 may also be analyzed
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
AUC(TAU) fraction unbound (AUC(TAU) fu) for (DCV, ASV, BMS-791325), BMS-794712 and BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
BMS-948158 may also be analyzed
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
Protein Binding for DCV, ASV, BMS-791325 and BMS-794712
Tidsramme: 1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)
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1 and 4 hours postdose on Day 10 (all subjects) and Day 12 (Group E only)
|
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Total amount recovered in urine (URt) for (DCV, ASV, BMS-791325) and BMS-794712
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
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Total percent of administered dose recovered in urine (%URt) for (DCV, ASV, and BMS-791325 only)
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Renal clearance (CLR) for DCV, ASV, BMS-791325, and BMS-794712
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Maximum observed concentration (Cmax) for BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Area under the concentration-time curve in 1 dosing interval (AUC (TAU)) for BMS-948158
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Safety based on occurrence of Adverse Event (AEs), Serious adverse event (SAEs) and AEs leading to discontinuation
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
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For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
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Safety based on abnormalities in vital sign measurements
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Safety based on findings on ECG measurements and physical examinations
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
|
Safety based on Marked abnormalities in clinical laboratory test findings
Tidsramme: For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
For Groups A-D: Day 1 to Day 11 and for Group E: Day 1 to Day 13
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- RNA-virusinfeksjoner
- Virussykdommer
- Infeksjoner
- Blodbårne infeksjoner
- Smittsomme sykdommer
- Leversykdommer
- Flaviviridae-infeksjoner
- Hepatitt, viral, menneskelig
- Hepatitt
- Hepatitt C
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Proteasehemmere
- Asunaprevir
Andre studie-ID-numre
- AI443-110
Legemiddel- og utstyrsinformasjon, studiedokumenter
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Studerer et amerikansk FDA-regulert enhetsprodukt
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