Table 4.
Summary of statistical analysis of primary PK parameters for BZG791 by hepatic function group (Pharmacokinetic analysis set)
| PK parameter (unit) | Group (Control, N=11; Moderate, N=6; Severe, N=6) |
Adjusted geo-mean | Comparison(s) | Group comparison | ||
|---|---|---|---|---|---|---|
| Geo-mean ratio | 90% CI | |||||
| Lower | Upper | |||||
| Cmax (ng/mL) | Control | 242 | - | - | - | - |
| Moderate | 228 | Moderate/Control | 0.942 | 0.639 | 1.39 | |
| Severe | 421 | Severe/Control | 1.74 | 1.18 | 2.56 | |
| AUClast (ng*hr/mL) | Control | 3110 | - | - | - | - |
| Moderate | 2750 | Moderate/Control | 0.883 | 0.598 | 1.30 | |
| Severe | 7620 | Severe/Control | 2.45 | 1.65 | 3.62 | |
| AUCinf (ng*hr/mL) | Control | 3200 | - | - | - | - |
| Moderate | 2840 | Moderate/Control | 0.887 | 0.608 | 1.29 | |
| Severe | 7640 | Severe/Control | 2.39 | 1.64 | 3.49 | |
| Tmax (hr) | Control | 4.00 | - | - | - | - |
| Moderate | 4.00 | Moderate/Control | 0 | - | - | |
| Severe | 6.00 | Severe/Control | 2.00 | - | - | |
AUCinf, area under the curve from time zero to infinity; CI, confidence interval; Cmax, maximum blood concentration; Tmax, time at which Cmax is reached.
For Tmax, median is presented under 'Adjusted geo-mean', difference of medians under 'Geo-mean ratio'.
Geometric mean ratio of the healthy control participant group and each one of the hepatic function groups was estimated using an ANCOVA model of the log-transformed PK parameters. Included in the model were hepatic function group as a fixed effect and sex as covariate for Cmax, hepatic function group, weight and sex as covariates for AUClast and AUCinf. The results were back transformed to get adjusted geometric mean, geometric mean ratio, and 90% CI.