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NCT00983957 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects
A Phase 1 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 1
- Development phase
- 47
- Enrollment target
- 3
- Study locations
NCT00983957: Completed Phase 1 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.
NCT00983957 is a Phase 1 study of Chronic Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 47 participants, below the 211-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00983957, a Phase 1 study of Chronic Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 47 participants
- Enrollment target
- 3
- Study locations
Study Summary
The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.
Primary Outcome
Ethinyl Estradiol is an analyte of Ortho Tri-Cyclen. Ethinyl Estradiol was measured in plasma, using liquid chromatography-tandem mass spectrometry (LC-MS/MS) by a validated analytical method during the period of known analyte stability. Cmax was measured in picograms per milliliter (pg/mL) and derived from 24 hour plasma concentration versus time data using non-compartmental methods. Pre-dose concentrations and concentrations prior to the first quantifiable concentration that were below the low
Conditions Studied
Interventions
- DRUG BMS-790052
- DRUG Ortho Tri-Cyclen®
Study Locations (3)
Arizona
- MDS Pharma Services (US), Inc - Tempe
Texas
- Covance Clinical Research Unit, Inc. - Austin
Quebec
- Local Institution - Saint-Laurent
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 47 participants |
| Start Date | 2009-10 |
| Est. Completion | 2010-02 |
| Phase | Phase 1 |
What the finished NCT00983957 record still lists
NCT00983957 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 211-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which BMS-790052 is the first listed.
NCT00983957 reports a single indexed study location in Arizona, Texas, Quebec.
Frequently Asked Questions
What is clinical trial NCT00983957 about?
NCT00983957 is a clinical study titled "Study to Assess the Effect of BMS-790052 on the Pharmacokinetics of Ortho Tri-Cyclen® in Healthy Female Subjects". The purpose of this study is to assess the effect of BMS-790052 on the pharmacokinetics of Ortho Tri-Cyclen® in healthy female subjects.
What is the current status of trial NCT00983957?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2009-10. Estimated completion is 2010-02.
What conditions does trial NCT00983957 study?
This clinical trial studies the following conditions: Chronic Hepatitis C.
What interventions are being tested in trial NCT00983957?
The interventions under investigation include: BMS-790052 (DRUG), Ortho Tri-Cyclen® (DRUG).
Who is sponsoring clinical trial NCT00983957?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00983957 being conducted?
This trial has 3 study locations across Arizona, Texas, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Hepatitis C
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 NCT00983957's enrollment target sits among peer trials
47 8th of 16 higher than 9 of 16 other Chronic Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Hepatitis C 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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