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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: Completed Phase 1 study, sponsored by Bristol-Myers Squibb.
NCT01445795 is a Phase 1 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 50 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT01445795 record still lists
NCT01445795 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 5 interventions - of which 200 mg INX-08189 Fasted is the first listed.
NCT01445795 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01445795's enrollment target sits among peer trials
50 973rd of 2000 higher than 984 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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