Chronic Hepatitis CPhase 1/2NCT00664625
A Single Ascending Dose Study of BMS-791325 in HCV Infected Subjects
A Phase 1/2 study testing BMS-791325 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 6 sites in 2 countries.
Trial summary
The primary purpose of this study is to evaluate the safety profile and tolerability of single oral doses of BMS-791325 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-791325
- 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
- 6 sitesin 2 countries
- Study dates
- May 2008to Jun 2009
- 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 35 kg/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
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
United States5 sites
Advanced Clinical Res Inst
Anaheim, California, 92801
West Coast Clinical Trials, Llc
Cypress, California, 90630
University Of Pennsylvania
Philadelphia, Pennsylvania, 19104
Alamo Medical Research
San Antonio, Texas, 78215
Washington University School Of Medicine
St Louis, Missouri, 63110
About this study
Official title: Placebo-Controlled Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of BMS-791325 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-791325 in subjects with chronic hepatitis C infection
- Conditions
- Chronic Hepatitis C
- Being tested
- BMS-791325, 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-791325Drug
Capsules, Oral, Once Daily, Single Dose
PlaceboDrug
Capsules, Oral, Once Daily, Single Dose
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | BMS-791325 (100 mg)
or
placebo match for (100 mg) Receives: Drug: BMS-791325; Drug: Placebo |
| 2 | Experimental | BMS-791325 (300 mg)
or
placebo match for (300 mg) Receives: Drug: BMS-791325; Drug: Placebo |
| 3 | Experimental | BMS-791325 (900 mg)
or
placebo match for (900 mg) Receives: Drug: BMS-791325; Drug: Placebo |
| 4 | Experimental | BMS-791325 (potential dose between 10-800 mg)
or
placebo match for (10-800 mg) Receives: Drug: BMS-791325; Drug: 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 posted23 Apr 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 (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
- NCT00664625
- Sponsor's protocol ID
- AI443-002
- Status last verified
- Sep 2015
- First submitted
- 18 Apr 2008
- Last updated
- 9 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Sims KD, Lemm J, Eley T, Liu M, Berglind A, Sherman D, Lawitz E, Vutikullird AB, Tebas P, Gao M, Pasquinelli C, Grasela DM. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection. Antimicrob Agents Chemother. 2014 Jun;58(6):3496-503. doi: 10.1128/AAC.02579-13. Epub 2014 Apr 14.
PubMed 24733462
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2015. 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-791325 in Subjects Chronically Infected With Hepatitis C Virus Genotype 1
- ClinicalTrials.gov ID
- NCT00664625
- Acronym / sponsor ID
- AI443-002
- Conditions
- Chronic Hepatitis C
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 23 Apr 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 evaluate the safety profile and tolerability of single oral doses of BMS-791325 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 |
|---|---|---|
| 1 | Experimental | Drug: BMS-791325, Drug: PlaceboBMS-791325 (100 mg) or placebo match for (100 mg) |
| 2 | Experimental | Drug: BMS-791325, Drug: PlaceboBMS-791325 (300 mg) or placebo match for (300 mg) |
| 3 | Experimental | Drug: BMS-791325, Drug: PlaceboBMS-791325 (900 mg) or placebo match for (900 mg) |
| 4 | Experimental | Drug: BMS-791325, Drug: PlaceboBMS-791325 (potential dose between 10-800 mg) or placebo match for (10-800 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 35 kg/m²
Key exclusion criteria (3 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
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-791325Capsules, Oral, Once Daily, Single Dose | Drug | 1, 2, 3, 4 |
| PlaceboCapsules, Oral, Once Daily, Single Dose | Drug | 1, 2, 3, 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 9 Oct 2015.
- Derived from this study: PubMed 24733462Sims KD, Lemm J, Eley T, Liu M, Berglind A, Sherman D, Lawitz E, Vutikullird AB, Tebas P, Gao M, Pasquinelli C, Grasela DM. Randomized, placebo-controlled, single-ascending-dose study of BMS-791325, a hepatitis C virus (HCV) NS5B polymerase inhibitor, in HCV genotype 1 infection. Antimicrob Agents Chemother. 2014 Jun;58(6):3496-503. doi: 10.1128/AAC.02579-13. Epub 2014 Apr 14.
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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
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BMS-791325 in people with Chronic Hepatitis C, run by Bristol-Myers Squibb at 6 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 3 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 9 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Argentina. 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?
On the ClinicalTrials.gov record for NCT00664625, which also lists 1 linked publication.
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 9 Oct 2015; AzTrials last refreshed its copy on 6 Nov 2026.