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NCT01448200 · ClinicalTrials.gov registry record · Phase 1
A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1
A Phase 1 study, sponsored by Presidio Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 82
- Enrollment target
NCT01448200 is a Phase 1 study that has completed, run by Presidio Pharmaceuticals. The registered enrollment target is 82 participants.
The verdict
NCT01448200, a Phase 1 study, has completed, sponsored by Presidio Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 82 participants
- Enrollment target
Study Summary
PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatitis C patients for up to 3 days (Part II). In addition, the study will assess how much PPI-668 is absorbed into the bloodstream. In Part II, the effect of PPI-668 on the amount of hepatitis C virus in patients' bloodstream (serum HCV RNA levels) also will be assessed.
Interventions
- DRUG Placebo
- DRUG PPI-668
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 82 participants |
| Start Date | 2011-10 |
| Est. Completion | 2012-11 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01448200
The ClinicalTrials.gov registry entry for NCT01448200 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 82 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Presidio Pharmaceuticals, which has 6 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01448200 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01448200 about?
NCT01448200 is a clinical study titled "A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1". PPI-668 is an antiviral agent (a hepatitis C NS5A inhibitor) that is being developed as a potential treatment for hepatitis C virus infection. This study is being done to assess the safety and tolerance of PPI-668 when given to healthy volunteers for up to 5 days (Part I of the study) and to hepatit...
What is the current status of trial NCT01448200?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 82 participants. The study started on 2011-10. Estimated completion is 2012-11.
What interventions are being tested in trial NCT01448200?
The interventions under investigation include: Placebo (DRUG), PPI-668 (DRUG).
Who is sponsoring clinical trial NCT01448200?
This trial is sponsored by Presidio Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
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