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

ContraVir Pharmaceuticals, Inc.16 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Renal Impairment

Interventions

Tenofovir Exalidex (TXL)DRUG

Drug: Tenofovir Exalidex (TXL)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Orlando Clinical Research Center

Orlando, Florida, United States

Outcomes

Primary Outcomes

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

Measuring Cmax : the peak plasma concentration

Time frame: up to six days post dose

Secondary Outcomes

Evaluation of the adverse events for TXL in RI subjects

review of Adverse events

Time frame: up to six days post dose

Evaluation of safety labs for TXL in RI subjects

review of safety labs

Time frame: up to six days post dose

Data from ClinicalTrials.gov

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