Lack of pharmacokinetic interaction between the HIV-1 maturation inhibitor GSK3640254 and combination oral contraceptives in healthy women.

ABSTRACT:

Aims

GSK3640254 is a next-generation maturation inhibitor likely to be coadministered with combined oral contraceptives in HIV-positive women.

Methods

This phase I, open-label, 1-way study assessed pharmacokinetic and pharmacodynamic interactions of GSK3640254 200 mg and ethinyl oestradiol 0.03 mg/levonorgestrel 0.15 mg once daily in healthy female participants who received ethinyl oestradiol/levonorgestrel for 10 days with a moderate-fat meal after which GSK3640254 was added from Days 11 to 21. Primary endpoints were area under the plasma concentration-time curve to the end of the dosing interval (AUC_0-t ), maximum observed concentration (C_max ) and plasma concentration at the end of the dosing interval (C_τ ) for ethinyl oestradiol and levon

SUBMITTER: Pene Dumitrescu T 

PROVIDER: S-EPMC9291532 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature