Recarbrio: genotox, carcinogenicity and repro: done or skipped?

“Relebactam was shown to be negative for mutagenicity and/or clastogeniceffects in an Ames assay, a chromosomal aberration study, and in vivo in a rat bone marrow micronucleus assay.”

“In the absence of genotoxicity, and as the proposed treatment duration is relatively short, no carcinogenicity tests have been conducted.”

“In rats and rabbits, malformations and variations were not increased by relebactam above concurrent or historical control levels. However, in mice, increases in specificexternal and/or skeletal alterations were observed.”

“No MK-7655-related changes compared to vehicle control values were observed for blood pressure measurements, heart rate, electrocardiogram parameters including QTc intervals, respiratory parameters, or body temperature.”

“The genotoxic potential of relebactam was characterized by the Ames test, a chromosome aberration test in CHO-cells, and an in-vivo rat bone marrow erythrocyte micronucleus test. The outcome of the studies was negative, thus, there were no indication that relebactam is genotoxic.”

“The genotoxic potential of relebactam was characterized by the Ames test, a chromosome aberration test in CHO-cells, and an in-vivo rat bone marrow erythrocyte micronucleus test. The outcome of the studies was negative, thus, there were no indication that relebactam is genotoxic.”

“The genotoxic potential of relebactam was characterized by the Ames test, a chromosome aberration test in CHO-cells, and an in-vivo rat bone marrow erythrocyte micronucleus test. The outcome of the studies was negative, thus, there were no indication that relebactam is genotoxic.”

“In the absence of genotoxicity, and as the proposed treatment duration is relatively short, no carcinogenicity tests have been conducted.”

“In the absence of genotoxicity, and as the proposed treatment duration is relatively short, no carcinogenicity tests have been conducted.”

“In a whole-cell voltage-clamping of CHO cells stably expressing hERG, REL had no significant effect on hERG current relative to time-dependent changes observed in the vehicle control, at a maximal testable actual concentration of 318 μM (~8-fold clinical free fraction Cmax, 38 µM).”