Phase 1
N=30
Single-Dose Pharmacokinetics of BMS-790052 in Participants With Hepatic Impairment
Hepatic Insufficiency
Bottom Line
View on ClinicalTrials.gov: NCT00859053 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Oct 2015
Primary outcome: Primary: Maximum Observed Plasma Concentration (Cmax) of BMS-790052 — 380; 382; 317; 698 nanograms/milliliter (ng/mL)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- BMS-790052 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bristol-Myers Squibb
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Observed Plasma Concentration (Cmax) of BMS-790052 |
380; 382; 317; 698 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve (AUC) From Time Zero to Last Measurable Concentration [AUC(0-T)] of BMS-790052 |
4151; 4490; 4534; 7165 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time Zero Extrapolated to Infinite Time [AUC(INF)] of BMS-790052 |
4174; 4550; 4649; 7286 | — |
| PRIMARY Time to Reach Maximum Observed Plasma Concentration (Tmax) of BMS-790052 |
1.5; 1.0; 1.5; 1.3 | — |
| PRIMARY Terminal Half-life (T-HALF) of BMS-790052 |
12.3; 15.0; 17.2; 12.4 | — |
| PRIMARY Apparent Total Body Clearance (CLT/F) of BMS-790052 |
120; 110; 108; 69 | — |
| PRIMARY Apparent Clearance of Free BMS-790052 (CLu/F) |
19529; 12028; 12468; 11796 | — |
| PRIMARY The Apparent Volume of Distribution at Steady State (Vss/F) |
98557; 111612; 123034; 61250 | — |
| SECONDARY Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died |
0; 0; 0; 0; 0; 0 | — |
Summary
The purpose of this study is to assess the effects of hepatic impairment on the single dose pharmacokinetics of BMS-790052.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00859053). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.