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NCT01445795 · ClinicalTrials.gov registry record · Phase 1
Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects
A Phase 1 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT01445795 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 50 participants.
The verdict
NCT01445795, a Phase 1 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV), Treatment-naïve subjects.
Interventions
- DRUG 200 mg INX-08189 Fasted
- DRUG Placebo QD Fasted
- DRUG 100 mg INX-08189 QD
- DRUG Placebo QD
- DRUG 100 mg INX-08189 with low-fat meal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2011-09 |
| Est. Completion | 2012-05 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01445795
The ClinicalTrials.gov registry entry for NCT01445795 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which 200 mg INX-08189 Fasted is the first listed.
NCT01445795 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01445795 about?
NCT01445795 is a clinical study titled "Safety Study of INX-08189, Pharmacokinetic and Pharmacodynamic With Ribavirin and Food Effect Study, in Chronically-infected Genotype 1 Hepatitis C Virus, Treatment-naïve Subjects". This study is to determine the safety and Pharmacokinetics (PK) and Pharmacodynamics (PD) of INH-08189 dosed once a day (QD), two times a day (BID) or adjunctively with Ribavirin and a study of the food effect in Chronically-infected Genotype 1 Hepatitis C Virus (HCV), Treatment-naïve subjects.
What is the current status of trial NCT01445795?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 2011-09. Estimated completion is 2012-05.
What interventions are being tested in trial NCT01445795?
The interventions under investigation include: 200 mg INX-08189 Fasted (DRUG), Placebo QD Fasted (DRUG), 100 mg INX-08189 QD (DRUG), Placebo QD (DRUG), 100 mg INX-08189 with low-fat meal (DRUG).
Who is sponsoring clinical trial NCT01445795?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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