Renal Impairment
Conditions
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
Interventions
Drug: Tenofovir Exalidex (TXL)
Sponsors
ContraVir Pharmaceuticals, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Tenofovir exalidex (TXL)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed