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

ContraVir Pharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Renal Impairment

Treatments: Drug: Tenofovir Exalidex (TXL)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03284164

CTRV-TXL-104

Details and patient eligibility

About

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

Full description

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

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Healthy Subjects

Experimental group

Description:

Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)

Treatment:

Drug: Tenofovir Exalidex (TXL)

Severe RI

Experimental group

Description:

Severe Renal Impairment subjects Tenofovir Exalidex (TXL)

Treatment:

Drug: Tenofovir Exalidex (TXL)