Overview

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

Status:
Withdrawn

Trial end date:
2021-11-01

Target enrollment:

Participant gender:

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

Phase:

Phase 4

Details

Lead Sponsor:

Yale University

Collaborator:

Gilead Sciences

Treatments:

Emtricitabine
Rifampin
Rifapentine