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

June 5, 2018 updated by: ContraVir Pharmaceuticals, Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32809
        • Orlando Clinical Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy Subjects
Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Other Names:
  • lipid conjugate TFV
Experimental: Severe RI
Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Other Names:
  • lipid conjugate TFV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Time Frame: up to six days post dose
Measuring Cmax : the peak plasma concentration
up to six days post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the adverse events for TXL in RI subjects
Time Frame: up to six days post dose
review of Adverse events
up to six days post dose
Evaluation of safety labs for TXL in RI subjects
Time Frame: up to six days post dose
review of safety labs
up to six days post dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ContraVir Pharmaceuticals, Inc.

Investigators

  • Study Chair: John Sullivan-Bolyai, MD, MPH, ContraVir Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 28, 2017

Primary Completion (Actual)

January 17, 2018

Study Completion (Actual)

February 20, 2018

Study Registration Dates

First Submitted

September 8, 2017

First Submitted That Met QC Criteria

September 14, 2017

First Posted (Actual)

September 15, 2017

Study Record Updates

Last Update Posted (Actual)

June 6, 2018

Last Update Submitted That Met QC Criteria

June 5, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTRV-TXL-104

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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