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NCT02357602 · ClinicalTrials.gov registry record · Phase 1
Dose Proportionality of TFV-DP After a Single Dose of GS-7340 in Women
A Phase 1 study of Healthy, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02357602: Completed Phase 1 study of Healthy, sponsored by University of North Carolina, Chapel Hill.
NCT02357602 is a Phase 1 study of Healthy that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 24 participants, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02357602, a Phase 1 study of Healthy, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
Purpose: The purpose of this study is to characterize the dose-proportionality in the distribution of tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues of healthy female subjects following a single oral dose of GS-7430 at 5mg, 10mg, and 25mg.
Primary Outcome
To characterize the dose-proportionality in the distribution of TAF and TFV in the plasma of healthy female subjects following a single oral dose of GS-7340 at 5mg, 10mg, and 25mg. This will be used to develop a predictive pharmacokinetic model for TAF which will allow for TFVdp exposure predictions given a specific dose and dosing interval.
Conditions Studied
Interventions
- DRUG GS-7340
Study Locations (1)
North Carolina
- University of North Carolina at Chapel Hill - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2015-03 |
| Est. Completion | 2016-11 |
| Phase | Phase 1 |
What the finished NCT02357602 record still lists
NCT02357602 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 647-participant average among 1,090 other Healthy trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Healthy appearing as the primary indexed condition, and to 1 intervention - of which GS-7340 is the first listed.
NCT02357602 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT02357602 about?
NCT02357602 is a clinical study titled "Dose Proportionality of TFV-DP After a Single Dose of GS-7340 in Women". Purpose: The purpose of this study is to characterize the dose-proportionality in the distribution of tenofovir alafenamide (TAF) and tenofovir (TFV) in plasma and mucosal tissues, and TFV-diphosphate (TFV-DP) in peripheral blood mononuclear cells (PBMCs) and mucosal tissues of healthy female subje...
What is the current status of trial NCT02357602?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2015-03. Estimated completion is 2016-11.
What conditions does trial NCT02357602 study?
This clinical trial studies the following conditions: Healthy.
What interventions are being tested in trial NCT02357602?
The interventions under investigation include: GS-7340 (DRUG).
Who is sponsoring clinical trial NCT02357602?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02357602 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Healthy
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02357602's enrollment target sits among peer trials
24 791st of 1090 higher than 254 of 1,090 other Healthy trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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