Table 3. Median single-dose (SD) PK parameters (all data points collected during the study).
Analyte, Matrix | N | N(>BLQ ) | Samples(>BLQ/Total #) | Cmax (ng/mL) | Tmax (hr) | AUC0–24 h (hr*ng/mL) | C24 h (ng/mL) |
SD | SD | SD | SD | ||||
TFV BP (IQR) | 48 | 48 | 313/392 (80%) | 4.0 (1.5–9.1) | 4 (2–6) | 36.4 (14.0–73.3) | 0.3 (0.3–0.5) |
TFV CVF | 45 | 45 | 52/52 (100%) | 1.9×106 | 4 | 20.7×106 | 0.1×106 |
TFV Vaginal Tissue | 33 | 333 | 72/72 (100%) | 2.2×105 | 2 | 64.0×104 | 0.7×104 |
TFV-DP ECC | 48 | 39 | 42/57 (74%) | 7.5×105 | 4 | 47.4×105 | 0.8×105 |
TFV-DP Vaginal Tissue | 33 | 154 | 36/72 (50%) | 3.8×103 | 1 | 12.4×103 | n/a |
TFV-DP ECC1 | 48 | 39 | 42/57 (74%) | 33.6×104 | 4 | 212.2×104 | 3.5×104 |
TFV-DP Vaginal Tissue2 | 33 | 15 | 36/72 (50%) | 1.7×103 | 1 | 5.6×103 | n/a |
Cmax and C24 h in fmol/106 cells; AUC0–24 h in hr * fmol/106 cells.
Cmax and C24 h in fmol/0.2 µL; AUC 0–24 h in hr * fmol/0.2 µL.
Thirty-six data points contributed to the TFV tissue analysis.
Fifteen data points out of a potential 36 contributed to the TFV-DP tissue analysis.