Table 6.
Nirmatrelvir-Related Clinical Pathology Findings in 1-Month Monkey Toxicity Study.
| Sex | Endpoint | Sampling time | Vehicle (Mean ± SD [n]) | 40 mg/kg (q.d.) (Mean ± SD [n]) | 100 mg/kg (q.d.) (Mean ± SD [n]) | 600 mg/kg (q.d.) (Mean ± SD [n]) |
|---|---|---|---|---|---|---|
| Male | Fibrinogen (mg/100 mL) | Baseline | 182.4 ± 19.1 (5) | 198.7 ± 39.6 (5) | 193.7 ± 22.1 (5) | 179.0 ± 30.0 (5) |
| Day 29 | 211.2 ± 6.8 (5) | 215.3 ± 45.7 (5) | 219.3 ± 26.7 (5) | 294.6 ± 39.7a,* (5) | ||
| Alanine aminotransferase (U/L) | Baseline | 42.0 ± 8.5 (5) | 34.3 ± 12.7 (5) | 48.0 ± 2.0 (5) | 57.4 ± 18.7 (5) | |
| Day 29 | 50.6 ± 9.2 (5) | 40.3 ± 14.2 (5) | 57.3 ± 11.0 (5) | 91.8 ± 25.2a,b,* (5) | ||
| Aspartate aminotransferase (U/L) | Baseline | 44.2 ± 9.4 (5)* | 31.3 ± 8.4 (5) | 48.0 ± 23.1 (5) | 48.6 ± 10.7 (5) | |
| Day 29 | 70.2 ± 19.4 (5) | 52.7 ± 19.9 (5) | 65.0 ± 19.7 (5) | 131.6 ± 70.2a,c* (5) | ||
| Female | Fibrinogen (mg/100 mL) | Baseline | 174.0 ± 13.9 (5) | 204.0 ± 75.2 (5) | 181.0 ± 23.3 (5) | 183.6 ± 28.7 (5) |
| Day 29 | 192.8 ± 13.5 (5) | 201.7 ± 44.6 (5) | 215.7 ± 35.5 (5) | 261.4 ± 19.6a,* (5) | ||
| Alanine aminotransferase (U/L) | Baseline | 49.4 ± 20.6 (5) | 42.0 ± 10.8 (5) | 48.3 ± 5.1 (5) | 40.4 ± 9.2 (5) | |
| Day 29 | 62.2 ± 15.7 (5) | 58.0 ± 27.1 (5) | 65.0 ± 7.5 (5) | 59.8 ± 13.1 (5) | ||
| Aspartate aminotransferase (U/L) | Baseline | 42.6 ± 13.0 (5) | 47.7 ± 12.7 (5) | 39.0 ± 11.8 (5) | 36.8 ± 8.0 (5) | |
| Day 29 | 57.8 ± 10.6 (5) | 60.3 ± 28.3 (5) | 46.3 ± 16.3 (5) | 78.6 ± 27.1a,c (5) |
aDenotes nirmatrelvir-related findings.
bMean increase caused by increases of 1.63-3.53× individual animal baseline in 2/5 males.
cMean increases caused by increases of 2.68-7.41× individual animal baseline in 2/5 males and 1/5 females.
Statistical analysis;*P < 0.05 following a pairwise comparison.