Evaluation of Effect of Renal Impairment on the PK of Tenofovir Exalidex
NCT ID: NCT03284164
Last Updated: 2018-06-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
16 participants
INTERVENTIONAL
2017-09-28
2018-02-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Healthy Subjects
Healthy Subjects matched to RI subjects Tenofovir Exalidex (TXL)
Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Severe RI
Severe Renal Impairment subjects Tenofovir Exalidex (TXL)
Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Interventions
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Tenofovir Exalidex (TXL)
Drug: Tenofovir Exalidex (TXL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Capable of giving written informed consent
* Capable of completing study requirements
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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ContraVir Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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John Sullivan-Bolyai, MD, MPH
Role: STUDY_CHAIR
ContraVir Pharmaceuticals
Locations
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Orlando Clinical Research Center
Orlando, Florida, United States
Countries
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Other Identifiers
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CTRV-TXL-104
Identifier Type: -
Identifier Source: org_study_id
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