A Study of the Pharmacokinetic and Pharmacodynamic Interactions Between Bictegravir, Tenofovir Alafenamide and Rifapentine in Healthy Adult Subjects

Summary

This is a single-center, open-label, fixed sequence, pharmacokinetic interaction study between bictegravir and tenofovir alafenamide with rifapentine dosed either daily or weekly. Primary Aims * To assess the effect of once-weekly rifapentine on the steady-state PK of BIC * To assess the effect of once-daily rifapentine on the steady-state PK of BIC Secondary Aims * To assess the effect of daily dosed rifapentine on steady-state PK of TAF (measured as plasma and IC concentrations of TFV-DP) * To assess the effect and timing of interactions of weekly dosed rifapentine on steady-state PK of TAF (measured as plasma and IC concentrations of TFV-DP) * To assess the safety of BIC/TAF/FTC when coadministered with once-weekly or once-daily rifapentine

Timeline

Start

2021-05

Primary completion

2021-10

Completion

2021-11

Drugs

Indications