Chronic Hepatitis CPhase 2NCT00722358
A Multiple Ascending Dose Study of BMS-650032 in HCV Infected Subjects
A Phase 2 study testing BMS-650032 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 5 sites in 2 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- BMS-650032
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Dec 2008to Dec 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Chronically infected with HCV genotype 1
- Treatment naive
- HCV RNA viral load of ≥10*5 IU/mL
- BMI 18 to 35kg/m²
Who cannot join
- 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
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Advanced Clinical Res Inst
Anaheim, California, 92801
Central Texas Clinical Research
Austin, Texas, 78705
Parexel International Corporation
Baltimore, Maryland, 21225
Orlando Clinical Research Center
Orlando, Florida, 32809
About this study
Official title: Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1
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
- Conditions
- Chronic Hepatitis C
- Being tested
- BMS-650032, Placebo
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-650032Drug
Capsule, Oral, Q12h, 3/5 days
Panel 1: 200 mg
Panel 2: 400 mg
Panel 3: 600 mg
PlaceboDrug
Capsule, Oral, Q 12h, 3/5 days
Panel 1: matching placebo
Panel 2: matching placebo
Panel 3: matching placebo
| Study group | Role | What they receive |
|---|---|---|
| BMS-650032 | Active comparator | Not described Receives: Drug: BMS-650032 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 28 days after drug
Safety Outcome Measures: Safety and tolerability assessments
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2008 (estimated)
- Study startDec 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00722358
- Sponsor's protocol ID
- AI447-004
- Status last verified
- Jun 2011
- First submitted
- 23 Jul 2008
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Antiviral Activity and Safety, Tolerability, and Pharmacokinetics of BMS-650032 in Subjects Infected With Hepatitis C Virus Genotype 1
- ClinicalTrials.gov ID
- NCT00722358
- Acronym / sponsor ID
- AI447-004
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-650032 | Active comparator | Drug: BMS-650032 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Chronically infected with HCV genotype 1
- Treatment naive
- HCV RNA viral load of ≥10*5 IU/mL
- BMI 18 to 35kg/m²
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-650032Capsule, Oral, Q12h, 3/5 days Panel 1: 200 mg Panel 2: 400 mg Panel 3: 600 mg | Drug | BMS-650032 |
| PlaceboCapsule, Oral, Q 12h, 3/5 days Panel 1: matching placebo Panel 2: matching placebo Panel 3: matching placebo | Drug | Placebo |
Primary outcome
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
Time frame: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period
3 secondary outcomes
PD-PK Relationship Measures: Asses relationship between antiviral activity and measures of exposure to BMS-650032
Time frame: 28 days after drug
Safety Outcome Measures: Safety and tolerability assessments
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BMS-650032 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: To assess the change in HCV RNA during dosing with BMS-650032 from baseline to Day 3 and during follow-up period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2011.