A Single Ascending Dose Study of BMS-790052 in HCV Infected Subjects

This study has been completed.

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00546715

First received: October 17, 2007

Last updated: September 10, 2010

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

October 17, 2007

Last Updated Date

September 10, 2010

Start Date ^ICMJE

November 2007

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Safety Outcome Measures [ Time Frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose ]

Change History

Complete list of historical versions of study NCT00546715 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose ] [ Designated as safety issue: No ]
Pharmacodynamic Measures [ Time Frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Pharmacokinetic Measures [ Time Frame: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose ]
Pharmacodynamic Measures [ Time Frame: Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels for a period of 7 days after dosing ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Single Ascending Dose Study of BMS-790052 in HCV Infected Subjects

Official Title ^ICMJE

Placebo-Controlled Single Ascending Dose Study ot Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-790052 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1

Brief Summary

The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-790052 in subjects with chronic hepatitis C infection

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Chronic Hepatitis C

Intervention ^ICMJE

Drug: BMS-790052
Oral Solution, Oral, Single Dose
Drug: Placebo
Oral Solution, Oral, Single Dose

Study Arm (s)

Active Comparator: Dose Panel A
BMS-790052 - 1 mg

Placebo - 0 mg
Interventions:
- Drug: BMS-790052
- Drug: Placebo
Active Comparator: Dose Panel B
BMS-790052 - 10 mg

Placebo - 0 mg
Interventions:
- Drug: BMS-790052
- Drug: Placebo
Active Comparator: Dose Panel C
BMS-790052 - 100 mg

Placebo - 0 mg
Interventions:
- Drug: BMS-790052
- Drug: Placebo
Active Comparator: Dose Panel D
BMS-790052 - 0.5 - 200 mg (to be determined)

Placebo - 0 mg
Interventions:
- Drug: BMS-790052
- Drug: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

May 2008

Primary Completion Date

May 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Chronically infected with HCV genotype 1
Treatment naive or treatment non-responders or treatment intolerant; and not co-infected with HIV or HBV
HCV RNA viral load of ≥10*5* IU/mL
BMI 18 to 35kg/m²

Exclusion Criteria:

Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

Gender

Both

Ages

18 Years to 49 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00546715

Other Study ID Numbers ^ICMJE

AI444-002

Has Data Monitoring Committee

Responsible Party

Study Director, Bristol-Myers Squibb

Study Sponsor ^ICMJE

Bristol-Myers Squibb

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bristol-Myers Squibb

Information Provided By

Bristol-Myers Squibb

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top