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NCT00546715 · ClinicalTrials.gov registry record · Phase 1

A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects

A Phase 1 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 1
Development phase
95
Enrollment target
7
Study locations

NCT00546715 is a Phase 1 study of Chronic Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 95 participants, below the 208-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (54% lower). The trial reports 7 study locations across 7 states.

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The verdict

NCT00546715, a Phase 1 study of Chronic Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 1
Development phase
95 participants
Enrollment target
7
Study locations

Study Summary

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG Daclatasvir

Study Locations (7)

California

  • Advanced Clinical Research Institute - Anaheim

Florida

  • Orlando Clinical Research Center - Orlando

Maryland

  • Parexel International Corporation - Baltimore

Minnesota

  • Mayo Clinic - Rochester

New Jersey

  • Bristol-Myers Squibb Clinical Pharmacology Unit - Hamilton

Pennsylvania

  • Thomas Jefferson University - Philadelphia

Virginia

  • University Of Virginia Digestive Health Center Of Excellence - Charlottesville

Trial Details

FieldValue
Enrollment Target 95 participants
Start Date 2007-11
Est. Completion 2008-05
Phase Phase 1

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT00546715

The ClinicalTrials.gov registry entry for NCT00546715 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 208-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (54% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00546715 reports 7 study locations spanning 7 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT00546715 about?

NCT00546715 is a clinical study titled "A Single Ascending Dose Study of Daclatasvir (BMS-790052) in Hepatitis C Virus Infected Subjects". The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of daclatasvir in subjects with chronic hepatitis C infection

What is the current status of trial NCT00546715?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 95 participants. The study started on 2007-11. Estimated completion is 2008-05.

What conditions does trial NCT00546715 study?

This clinical trial studies the following conditions: Chronic Hepatitis C.

What interventions are being tested in trial NCT00546715?

The interventions under investigation include: Placebo (DRUG), Daclatasvir (DRUG).

Who is sponsoring clinical trial NCT00546715?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00546715 being conducted?

This trial has 7 study locations across California, Florida, Maryland, Minnesota, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.