Back to resultsEvaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
Primary Purpose
Renal Impairment
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Tenofovir Exalidex (TXL)
Sponsored by
About this trial
This is an interventional treatment trial for Renal Impairment
Eligibility Criteria
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
Sites / Locations
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Healthy Subjects
Severe RI
Arm Description
Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
Outcomes
Primary Outcome Measures
Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Measuring Cmax : the peak plasma concentration
Secondary Outcome Measures
Evaluation of the adverse events for TXL in RI subjects
review of Adverse events
Evaluation of safety labs for TXL in RI subjects
review of safety labs
Full Information
NCT ID
NCT03284164
First Posted
September 8, 2017
Last Updated
June 5, 2018
Sponsor
ContraVir Pharmaceuticals, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT03284164
Brief Title
Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
Official Title
An Open-Label Study to Investigate the Effect of Renal Impairment on the Pharmacokinectics of Tenofovir Exalidex
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 28, 2017 (Actual)
Primary Completion Date
January 17, 2018 (Actual)
Study Completion Date
February 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ContraVir Pharmaceuticals, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Tenofovir exalidex (TXL)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Subjects
Arm Type
Experimental
Arm Description
Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
Arm Title
Severe RI
Arm Type
Experimental
Arm Description
Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
Intervention Type
Drug
Intervention Name(s)
Tenofovir Exalidex (TXL)
Other Intervention Name(s)
lipid conjugate TFV
Intervention Description
Drug: Tenofovir Exalidex (TXL)
Primary Outcome Measure Information:
Title
Evaluation of the pharmacokinetics of TXL in subjects with RI compared to matching healthy volunteers
Description
Measuring Cmax : the peak plasma concentration
Time Frame
up to six days post dose
Secondary Outcome Measure Information:
Title
Evaluation of the adverse events for TXL in RI subjects
Description
review of Adverse events
Time Frame
up to six days post dose
Title
Evaluation of safety labs for TXL in RI subjects
Description
review of safety labs
Time Frame
up to six days post dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Sullivan-Bolyai, MD, MPH
Organizational Affiliation
ContraVir Pharmaceuticals
Official's Role
Study Chair
Facility Information:
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
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