Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
- Registration Number
- NCT03284164
- Lead Sponsor
- ContraVir Pharmaceuticals, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Healthy Subjects Tenofovir Exalidex (TXL) Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL) Severe RI Tenofovir Exalidex (TXL) Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
- Primary Outcome Measures
Name Time Method Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers up to six days post dose Measuring Cmax : the peak plasma concentration
- Secondary Outcome Measures
Name Time Method Evaluation of the adverse events for TXL in RI subjects up to six days post dose review of Adverse events
Evaluation of safety labs for TXL in RI subjects up to six days post dose review of safety labs
Trial Locations
- Locations (1)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States