Summary of lesogaberan dosing regimens and plasma samples analyzed (a subset of all samples obtained) in the clinical and preclinical studies
| Study No. | Species | Lesogaberan Dose(s) | Dosing before Plasma Samples | Time of Obtaining Plasma Samples after Dosing (h) |
|---|---|---|---|---|
| C00017 | Humans | 100 mg (14C-labeled) | Single dose | 1, 2, 3, 4, 6, 8, 12, 18, 24 |
| C00030 | Humans | 400 mg | Single dose | 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 36, 48 |
| C00030 | Humans | 400 mg | Twice daily for 5 days | 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12 |
| VKS0499 | Beagle dogs | 28 mg/kg | Once daily for 52 weeks | 0.5, 1, 2, 4, 8, 24 |
| VKS0664 | Rats (male) | 35, 90, 176 mg/kg | Once daily for 7 days | 0.5, 1, 3, 5, 8, 12, 18, 24 |
| VKS0507 | Rats (male/female) | 10, 30, 90 mg/kg | Once daily for 52 weeks | 0.5, 1, 3, 8, 24 |