NCT00722358

Brief Summary

The primary purpose of this study is to assess the change in HCV RNA during dosing with BMS-650032 and during the follow-up period in subjects with chronic hepatitis C infection

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2008

Shorter than P25 for phase_2

Geographic Reach
2 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 25, 2008

Completed
4 months until next milestone

Study Start

First participant enrolled

December 1, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

June 27, 2011

Status Verified

June 1, 2011

Enrollment Period

1 year

First QC Date

July 23, 2008

Last Update Submit

June 15, 2011

Conditions

Chronic Hepatitis C

Outcome Measures

Primary Outcomes (1)

  • Antiviral activity will be assessed by the magnitude and rate of change in plasma HCV RNA levels from baseline. The primary endpoint for antiviral activity is decrease from baseline in plasma HCV RNA levels to Day 3/ or 5

    To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period

Secondary Outcomes (3)

  • PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032

    28 days after drug

  • Safety Outcome Measures: Safety and tolerability assessments

    will be performed for a period of 28 days after administration of multiple doses of BMS-650032 for 3/ or 5 days

  • Pharmacokinetic Measures: Pharmacokinetic assessments

    will be done on Day 1 for one dosing interval after the AM dose and on Day 3/ or 5 for 72 hours after the last AM dose

Study Arms (2)

BMS-650032

ACTIVE COMPARATOR
Drug: BMS-650032

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

BMS-650032DRUG

Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg

BMS-650032
PlaceboDRUG

Capsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Chronically infected with HCV genotype 1
  • Treatment naive
  • HCV RNA viral load of ≥10\*5 IU/mL
  • BMI 18 to 35kg/m²

You may not qualify if:

  • Women of childbearing potential (WOCBP)
  • Any significant acute or chronic medical illness which is not stable or is not controlled with medication and not consistent with HCV infection
  • HCV infected subjects who are treatment non-responder (defined as subject who received at least 12 weeks of SOC and continue to have a detectable HCV RNA level or subjects who did not attain a 2-log decline in HCV RNA levels at 12 weeks and stopped treatment
  • HCV infected subjects who are treatment intolerant (defined as subject who are unable to receive at least 12 weeks of SOC due to toxicities associated with interferon and/or ribavirin
  • HIV and/or HBV positive
  • Major surgery within 4 weeks of study drug administration and any gastrointestinal surgery that could impact the absorption of study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Advanced Clinical Res Inst

Anaheim, California, 92801, United States

Location

Orlando Clinical Research Center

Orlando, Florida, 32809, United States

Location

Parexel International Corporation

Baltimore, Maryland, 21225, United States

Location

Central Texas Clinical Research

Austin, Texas, 78705, United States

Location

Local Institution

Santurce, 00909, Puerto Rico

Location

Related Links

MeSH Terms

Conditions

Hepatitis C, Chronic

Interventions

asunaprevir

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bristol-Myers Squibb

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 23, 2008

First Posted

July 25, 2008

Study Start

December 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 27, 2011

Record last verified: 2011-06

Locations

PR(1)US(4)