Nonteratogenicity of a structural analog of thalidomide in pregnant baboons (Papio cynocephalus)

Abstract

Teratologic evaluation of a mild tranquilizer being developed for human therapeutic use involved daily oral administration to 29 baboons (P. cynocephalus) during organogenesis according to three treatment regimens. In Phase I, 9 animals (3 groups of 3) received 2, 6, or 20 mg/kg CG 3033 per day for 28 consecutive days between 18 and 45 days gestation; in Phase II, 14 animals (7 groups of 2) were given 20 mg/kg CG 3033 for four consecutive days: 18-21, 22-25, 26-29, 30-33, 34-37, 38-41, or 42-45; and in Phase III, 6 animals (2 groups of 3) were administered 40 mg/kg daily between days 18-21 or 22-25 of gestation. No teratologic changes attributable to drug treatment were observed, and the abortion rate was within the range for controls.