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NCT03284164 Clinical Trial

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

Renal Impairment Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03284164
Other study ID # CTRV-TXL-104
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 28, 2017
Est. completion date February 20, 2018

Study information
Verified date February 2018
Source ContraVir Pharmaceuticals, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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 information / eligibility
Status Completed
Enrollment 16
Est. completion date February 20, 2018
Est. primary completion date January 17, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)

Locations
Country Name City State
United States Orlando Clinical Research Center Orlando Florida

Sponsors (1)
Lead Sponsor Collaborator
ContraVir Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers Measuring Cmax : the peak plasma concentration up to six days post dose
Secondary Evaluation of the adverse events for TXL in RI subjects review of Adverse events up to six days post dose
Secondary Evaluation of safety labs for TXL in RI subjects review of safety labs up to six days post dose
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