Chronic Hepatitis CPhase 1/2NCT00559247
A Single Ascending Dose Study of BMS-650032 in HCV Infected Subjects
A Phase 1/2 study of Chronic Hepatitis C, run by Bristol-Myers Squibb at 5 sites in United States.
Trial summary
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2008to Jul 2008
- Phase
- Phase 1/2
- 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 or treatment non-responders or treatment intolerant
- HCV RNA viral load of ≥10*5 IU/mL
- BMI 18 to 35kg/m²
Who cannot join
- 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
- Co-infection with HIV or HBV
- Women of childbearing potential
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Parexel International Corporation
Baltimore, Maryland, 21225
West Coast Clinical Trials, Llc
Cypress, California, 90630
Orlando Clinical Research Center
Orlando, Florida, 32809
Mayo Clinic
Rochester, Minnesota, 55905
Alamo Medical Research
San Antonio, Texas, 78215
About this study
Official title: Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
- Conditions
- Chronic Hepatitis C
- Being tested
- BMS-650032 or 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-650032 or PlaceboDrug
Oral, Once daily, Single Dose
| Study group | Role | What they receive |
|---|---|---|
| or Placebo - Dose Panel 1 | Experimental | Oral Suspension, 10 mg Receives: Drug: BMS-650032 or Placebo |
| or Placebo - Dose Panel 2 | Experimental | Oral Suspension 50 mg Receives: Drug: BMS-650032 or Placebo |
| or Placebo - Dose Panel 3 | Experimental | Oral Suspension, 200 mg Receives: Drug: BMS-650032 or Placebo |
| or Placebo - Dose Panel 4 | Experimental | Oral Suspension or Solution, 2.5 to 600 mg Receives: Drug: BMS-650032 or Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Outcome Measures
Measured: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
Secondary outcomes (2)
Pharmacokinetic Measures
Measured: Pharmacokinetic assessments will be done for a period of 72 hours following administration of a single oral dose
Pharmacodynamic Measures
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2007 (estimated)
- Study startJan 2008
- Primary completionJul 2008
- Study completionJul 2008
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
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
- NCT00559247
- Sponsor's protocol ID
- AI447-002
- Status last verified
- Sep 2010
- First submitted
- 15 Nov 2007
- Last updated
- 13 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-650032 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
- ClinicalTrials.gov ID
- NCT00559247
- Acronym / sponsor ID
- AI447-002
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Jan 2008
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 16 Nov 2007 (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 evaluate the safety profile and tolerability of single oral doses of BMS-650032 in subjects with chronic hepatitis C infection
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| or Placebo - Dose Panel 1 | Experimental | Drug: BMS-650032 or PlaceboOral Suspension, 10 mg |
| or Placebo - Dose Panel 2 | Experimental | Drug: BMS-650032 or PlaceboOral Suspension 50 mg |
| or Placebo - Dose Panel 3 | Experimental | Drug: BMS-650032 or PlaceboOral Suspension, 200 mg |
| or Placebo - Dose Panel 4 | Experimental | Drug: BMS-650032 or PlaceboOral Suspension or Solution, 2.5 to 600 mg |
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 or treatment non-responders or treatment intolerant
- HCV RNA viral load of ≥10*5 IU/mL
- BMI 18 to 35kg/m²
Key exclusion criteria (4 listed)
- 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
- Co-infection with HIV or HBV
- Women of childbearing potential
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-650032 or PlaceboOral, Once daily, Single Dose | Drug | or Placebo - Dose Panel 1, or Placebo - Dose Panel 2, or Placebo - Dose Panel 3, or Placebo - Dose Panel 4 |
Primary outcome
Safety Outcome Measures
Time frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose
2 secondary outcomes
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
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 13 Sep 2010.
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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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study of Chronic Hepatitis C, run by Bristol-Myers Squibb at 5 sites in United States.
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 4 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 13 Sep 2010. 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. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Safety Outcome Measures (time frame: Safety and tolerability assessments will be performed for a period of 7 days after administration of a single dose). 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 13 Sep 2010.