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Completed

NCT Number: NCT03279146

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

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

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Key information

Conditions

Healthy Volunteers

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Clinical

Nottingham, United Kingdom

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age:18-55 Capable of giving written informed consent Capable of completing study requirements

Exclusion criteria

  • History or medical condition which could impact patient safety History of drug or alcohol abuse within past 2 years Positive result for HIV, HBV, or HCV Participation in another clinical trial within the past 90 days

Treatment and study plan

Tenofovir Exalidex (TXL)

Drug

Oral formulations

Other names: Lipid conjugate YTFV

Primary outcomes

  1. Evaluation of pharmacokinetics of single dose oral formulations of TXL in fasted state

    Time frame: up to four days post dose

    Measuring Cmax, the peak plasma concentration

Sponsors and collaborators

Lead sponsor

ContraVir Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 12, 2017
Registry last updated
Aug 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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