NCT03279146

A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects

Open-Label, Part-Randomized Study Designed to Evaluate the PK Profile of Tenofovir Exalidex (TXL) Following Single Dose of Oral Formulations in Comparison to a Reference IR TXL Tablet in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: ContraVir Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1 study to evaluate the PK profile of TXL oral formulations in healthy subjects

Detailed description

This is a Phase 1 study to evaluate the PK profile of different oral formulations of TXL following single dose administration in healthy subjects.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Tenofovir exalidex (TXL)	Oral formulations

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-06-09
• Completion: 2018-06-16
• First posted: 2017-09-12
• Last updated: 2018-08-02

Locations

1 site across 1 country: United Kingdom

Regulatory

• FDA-regulated drug study