Table 6 The main PK parameters of 116-N1 under fasting and fed conditions after a single oral dose of 400 mg VV116.

From: Safety, tolerability, and pharmacokinetics of VV116, an oral nucleoside analog against SARS-CoV-2, in Chinese healthy subjects

Pharmacokinetic parameters

Fasting (n = 12)

Standard meal (n = 12)

High-fat meal (n = 12)

AUC0-t (h·ng/mL)

10443 (2031)

12405 (1941)

13107 (2042)

AUC0-∞ (h·ng/mL)

10962 (2020)

12889 (1947)

13600 (2126)

Cmax (ng/mL)

1523 (434)

1583 (273)

1602 (270)

Tmax (h)

1.50 (1.00, 4.00)

3.00 (1.50, 6.00)

2.50 (1.00, 6.00)

t1/2 (h)

5.66 (0.700)

5.31 (0.651)

5.47 (0.787)

Vd/F (L)

308 (72.2)

240 (31.8)

234 (22.6)

CL/F (L/h)

37.7 (7.23)

31.7 (4.89)

30.1 (4.62)

FE_ Cmax (%)

 

106.60 (93.40, 121.67)*

107.92 (94.56, 123.18)**

FE_ AUC0-t (%)

 

119.52 (114.50, 124.76)*

126.32 (121.01, 131.85)**

FE_ AUC0-∞(%)

 

118.21 (113.53, 123.08)*

124.67 (119.74, 129.81)**

  1. AUC0-t area under the concentration–time curve from time zero to the time of the last measurable concentration, AUC0-∞ area under the concentration–time curve from time zero to infinity, Cmax maximum observed plasma concentration, Tmax time to maximum plasma concentration, t1/2 terminal elimination half-life, Vd/F apparent distribution volume, CL/F clearance rate, FE food effect.
  2. Note: Data are expressed as Mean (SD), except for Tmax, which is shown as median (min, max).
  3. *Geometric mean ratios (90% CIs) of Cmax, AUC0-t and AUC0-n between standard meal and fasting.
  4. **Geometric mean ratios (90% CIs) of Cmax, AUC0-t and AUC0-∞ between high-fat meal and fasting.
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