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

ContraVir Pharmaceuticals, Inc.1 site in 1 country16 target enrollmentSeptember 28, 2017

ConditionsRenal Impairment

InterventionsTenofovir Exalidex (TXL)

DrugsTenofovir Exalidex (TXL)

Overview

Phase: Phase 1
Intervention: Tenofovir Exalidex (TXL)
Conditions: Renal Impairment
Sponsor: ContraVir Pharmaceuticals, Inc.
Enrollment: 16
Locations: 1
Primary Endpoint: Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

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

Registry

clinicaltrials.gov

Start Date

September 28, 2017

End Date

February 20, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ContraVir Pharmaceuticals, Inc.

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

Healthy Subjects

Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)

Intervention: Tenofovir Exalidex (TXL)

Severe RI

Severe Renal Impairment subjects Tenofovir Exalidex (TXL)

Intervention: Tenofovir Exalidex (TXL)

Outcomes

Primary Outcomes

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

Evaluation of the adverse events for TXL in RI subjects(up to six days post dose)
Evaluation of safety labs for TXL in RI subjects(up to six days post dose)