Hepatitis C VirusPhase 1NCT00947245
Japanese Bridging Study Conducted in the United States
A Phase 1 study testing BMS-791325 in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects. Read more about this study
- Who is it for?
- Ages 20 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C Virus
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Feb 2015
- Phase
- Phase 1
- 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 20 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
- First generation Japanese. Subject born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry
Who cannot join
- Any significant acute or chronic medical illness.
- Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
- Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
- History of eczema, psoriasis, or any intermittent or active dermatitis.
- Positive for HIV or HCV
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.
- Conditions
- Hepatitis C Virus
- Being tested
- BMS-791325, Placebo
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-791325Drug
Capsules, Oral, 300 mg, Single Dose, One day
BMS-791325Drug
Capsules, Oral, 900 mg, Single Dose, One day
BMS-791325Drug
Capsules, Oral, ≤1200 mg, Single Dose, One day
BMS-791325Drug
Capsules, Oral, 300 mg, Every 12 hours, 14 days
BMS-791325Drug
Capsules, Oral, 900 mg, once daily 14 days
BMS-791325Drug
Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days
PlaceboDrug
Capsules, Oral, Single Dose, One day
PlaceboDrug
Capsules, Oral, Every 12 hours, 14 days
PlaceboDrug
Capsules, Oral, Once Daily, 14 days
PlaceboDrug
Capsules, Oral, Every 12 hours or once daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-791325 - Part A, Dose 1 | Experimental | Not described Receives: Drug: BMS-791325; Drug: Placebo |
| BMS-791325 - Part A, Dose 2 | Experimental | Not described Receives: Drug: BMS-791325; Drug: Placebo |
| BMS-791325 - Part A, Dose 3 | Experimental | Not described Receives: Drug: BMS-791325; Drug: Placebo |
| BMS-791325 - Part B, Dose 1 | Experimental | Not described Receives: Drug: BMS-791325; Drug: Placebo |
| BMS-791325 - Part B, Dose 2 | Experimental | Not described Receives: Drug: BMS-791325; Drug: Placebo |
| BMS-791325 - Part B, Dose 3 | Experimental | Not described Receives: Drug: BMS-791325; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)
Measured: From time of dose to up to 14 days after last dose
Secondary outcomes (1)
To measure concentration of study drug following single and multiple doses
Measured: Within 48 or 72 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2009 (estimated)
- Study startOct 2014
- Primary completionFeb 2015 (estimated)
- Study completionFeb 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C VirusStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00947245
- Sponsor's protocol ID
- AI443-011
- Status last verified
- Jul 2013
- First submitted
- 27 Jul 2009
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Single and Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-791325 in Healthy Japanese Subjects
- ClinicalTrials.gov ID
- NCT00947245
- Acronym / sponsor ID
- AI443-011
- Conditions
- Hepatitis C Virus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Feb 2015 (estimated)
- First posted
- 28 Jul 2009 (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 purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics following single oral and multiple oral doses BMS-791325 in healthy Japanese subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| BMS-791325 - Part A, Dose 1 | Experimental | Drug: BMS-791325, Drug: Placebo |
| BMS-791325 - Part A, Dose 2 | Experimental | Drug: BMS-791325, Drug: Placebo |
| BMS-791325 - Part A, Dose 3 | Experimental | Drug: BMS-791325, Drug: Placebo |
| BMS-791325 - Part B, Dose 1 | Experimental | Drug: BMS-791325, Drug: Placebo |
| BMS-791325 - Part B, Dose 2 | Experimental | Drug: BMS-791325, Drug: Placebo |
| BMS-791325 - Part B, Dose 3 | Experimental | Drug: BMS-791325, Drug: Placebo |
Who may qualify
- Ages
- 20 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male and female subjects aged 20 to 49 years, with BMI of 18-30 kg/m2
- First generation Japanese. Subject born in Japan and has not lived outside of Japan for > 10 years, and subject can trace maternal and paternal Japanese ancestry
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness.
- Women who are pregnant, breastfeeding, or unwilling or unable to use an acceptable method of birth control.
- Gastrointestinal disease that may impact the absorption of study drug or that required treatment with a protocon inhibitor, antacid or H2 blocker.
- History of eczema, psoriasis, or any intermittent or active dermatitis.
- Positive for HIV or HCV
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, 300 mg, Single Dose, One day | Drug | BMS-791325 - Part A, Dose 1 |
| BMS-791325Capsules, Oral, 900 mg, Single Dose, One day | Drug | BMS-791325 - Part A, Dose 2 |
| BMS-791325Capsules, Oral, ≤1200 mg, Single Dose, One day | Drug | BMS-791325 - Part A, Dose 3 |
| BMS-791325Capsules, Oral, 300 mg, Every 12 hours, 14 days | Drug | BMS-791325 - Part B, Dose 1 |
| BMS-791325Capsules, Oral, 900 mg, once daily 14 days | Drug | BMS-791325 - Part B, Dose 2 |
| BMS-791325Capsules, Oral, ≤1200 mg, Every 12 hours or once daily, 14 days | Drug | BMS-791325 - Part B, Dose 3 |
| PlaceboCapsules, Oral, Single Dose, One day | Drug | BMS-791325 - Part A, Dose 1, BMS-791325 - Part A, Dose 2, BMS-791325 - Part A, Dose 3 |
| PlaceboCapsules, Oral, Every 12 hours, 14 days | Drug | BMS-791325 - Part B, Dose 1 |
| PlaceboCapsules, Oral, Once Daily, 14 days | Drug | BMS-791325 - Part B, Dose 2 |
| PlaceboCapsules, Oral, Every 12 hours or once daily, 14 days | Drug | BMS-791325 - Part B, Dose 3 |
Primary outcome
Safety (adverse events, physical examinations, clinical labs, ECGs, vital signs)
Time frame: From time of dose to up to 14 days after last dose
1 secondary outcome
To measure concentration of study drug following single and multiple doses
Time frame: Within 48 or 72 hours postdose
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-791325 in people with Hepatitis C Virus, run by Bristol-Myers Squibb at 1 site 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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 18 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
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 was withdrawn before enrolling participants, so there are no results.
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 (adverse events, physical examinations, clinical labs, ECGs, vital signs) (time frame: From time of dose to up to 14 days after last 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 18 Jul 2013.