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Completed

NCT Number: NCT03284164

Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex

This is a Phase 1 study to investigate the effects of Renal Impairment on the pharmacokinetics of Tenofovir exalidex

Completed

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

About this study

This is a Phase 1 study to investigate the effects of Renal Impairment (mild, moderate and severe) on the pharmacokinetics of Tenofovir Exalidex

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age: 18 years of age and over
  • Capable of giving written informed consent
  • Capable of completing study requirements

Exclusion criteria

  • Positive result for HIV, HBV, or HCV
  • History or medical condition which could impact patient safety
  • Current or past abuse of alcohol or drugs
  • Participation in another clinical trial within the past 30 days

Treatment and study plan

Tenofovir Exalidex (TXL)

Drug

Drug: Tenofovir Exalidex (TXL)

Other names: lipid conjugate TFV

Primary outcomes

  1. Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers

    Time frame: up to six days post dose

    Measuring Cmax : the peak plasma concentration

Secondary outcomes

  1. Evaluation of the adverse events for TXL in RI subjects

    Time frame: up to six days post dose

    review of Adverse events

  2. Evaluation of safety labs for TXL in RI subjects

    Time frame: up to six days post dose

    review of safety labs

Sponsors and collaborators

Lead sponsor

ContraVir Pharmaceuticals, Inc.

Industry

Registry information

Official study title

An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Sep 15, 2017
Registry last updated
Jun 6, 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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