Dose Proportionality of TFV-DP After a Single Dose of GS-7340 in Women

Phase 1 Completed 24 enrolled University of North Carolina, Chapel Hill Gilead Sciences · collab

Non-randomizedSingle-groupOpen-labelPrevention

Summary

Purpose: The purpose of this study is to characterize the dose-proportionality in the distribution of tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues of healthy female subjects following a single oral dose of GS-7430 at 5mg, 10mg, and 25mg.

Timeline

Start: 2015-03
Primary completion: 2015-10
Completion: 2016-11

Publications

Cottrell ML, Garrett KL, Prince HMA, Sykes C, Schauer A, Emerson CW, Peery A, Rooney JF, McCallister S, Gay C, Kashuba ADM. Single-dose pharmacokinetics of tenofovir alafenamide and its active metabolite in the mucosal tissues. J Antimicrob Chemother. 2017 Jun 1;72(6):1731-1740. doi: 10.1093/jac/dkx064.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	tenofovir alafenamide	Small molecule	5 mg	Oral
Subject	tenofovir alafenamide	Small molecule	10 mg	Oral
Subject	tenofovir alafenamide	Small molecule	25 mg	Oral

Indications

No indication recorded.