TABLE 1.
Experimental design.
| Group | Test material | Dose route | Dose level (mg/kg/d) | Dose volume a (ml/kg) | Dose concentration (mg/ml) | Number of animals b | |
|---|---|---|---|---|---|---|---|
| Males | Females | ||||||
| 1 | Vehicle control | Oral gavage | 0 | 5 | 0 | 15 | — |
| 2 | REL-1017 | Oral gavage | 31.25 | 5 | 6.25 | 15 | — |
| 3 | REL-1017 | Oral gavage | 62.5 | 5 | 12.5 | 15 | — |
| 4 | REL-1017 | Oral gavage | 110 | 5 | 22 | 15 | — |
| 5 | Methadone racemate | Oral gavage | 31.25 | 5 | 6.25 | 15 | — |
| 6 | MK-801 (positive control) | Subcutaneous | 5 | 1 | 5 | 15 | — |
| 7 | Vehicle control | Oral gavage | 0 | 5 | 0 | — | 15 |
| 8 | REL-1017 | Oral gavage | 20 | 5 | 4 | — | 15 |
| 9 | REL-1017 | Oral gavage | 40 | 5 | 8 | — | 15 |
| 10 | REL-1017 | Oral gavage | 80 | 5 | 16 | — | 15 |
| 11 | Methadone racemate | Oral gavage | 20 | 5 | 4 | — | 15 |
| 12 | MK-801 (positive control) | Subcutaneous | 2 | 1 | 2 | — | 15 |
a
Based on the most recent body weight measurement.
b
Five animals/sex/group were euthanized on Day 1 (8 h post first dose), on Day 3 (24 h after the second dose), and on Day 5 (24 h after the fourth dose). Designated animals in Groups 6 and 12 were euthanized at approximately the same time as the cohorts in the corresponding REL-1017, groups.