GS-9674 / GS-0976 + Ethinyl Estradiol/Drosperinone = Unknown or no reaction

Effect on Concentration

GS-9674 / GS-0976
No change
Applies within class?
No
Ethinyl Estradiol/Drosperinone
Increase
Applies within class?
No

Pharmacologic Effects

GS-9674 / GS-0976
Effect
N/A
Applies within class?
No
Ethinyl Estradiol/Drosperinone
Effect
N/A
Applies within class?
No

Interaction History

N/A

Last Updated 24-Apr-2019

Summary

GS-0976 did not affect drosperinone pharmacokinetics and modestly increased ethinyl estradiol concentration (1.4X). However, the change in concentration of ethinyl estradiol is not clinically significant. Therefore, the use of GS-0976 with oral contraceptives is permitted in clinical trials without dose modification.

Sources

GS-0976 versus ethinyl Estradiol/Drosperinone ^

Study Design

Healthy subjects were administered single doses drospirenone/ethinyl estradiol (DRSP/EE 3/0.02mg; representative hormonal contraceptive), alone or in combination with GS-0976 50mg (QD 10 days).

Study Results

GS-0976 did not affect drosperinone pharmacokinetics and modestly increased ethinyl estradiol concentration (1.4X).

Study Conclusions

The authors concluded that the use of GS-0976 with oral contraceptives is permitted in clinical trials without dose modification.

References

Weber, E, Nelson, C, Vesterdahl, A, McColgan, B, Qin, A, Kirby, B. Evaluation of cytochrome p450- and transporter-mediated drug-drug interactions with the acetyl-coa carboxylase inhibitor gs0976 and phenotypic probe substrates and inhibitors . American Association For The Study Of Liver Diseases. 2018; : .