Accelerated Intimal HyperplasiaPhase 1NCT01049165
Single Ascending Dose (BMS-813160) Study
A Phase 1 study testing BMS-813160 and [14C] BMS-813160 in people with Accelerated Intimal Hyperplasia, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Accelerated Intimal Hyperplasia
- What is being tested?
- BMS-813160 and [14C] BMS-813160
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Nov 2010
- 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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women (not of child bearing potential) ages 18 to 45
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Who cannot join
- Women of Child Bearing Potential
- Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Trial locations and contacts
1 site in 1 country.
United States1 site
Covance Clinical Research Unit, Inc.
Madison, Wisconsin, 53704
About this study
Official title: Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects
The primary purpose of this study is to evaluate the safety and tolerability of single oral doses of BMS-813160 in healthy subjects
- Conditions
- Accelerated Intimal Hyperplasia
- Being tested
- BMS-813160, [14C] BMS-813160, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-813160Drug
Oral Solution, Oral, 5 mg, Single dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 20 mg, Single dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 60 mg, Single dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 150 mg, Single dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 300 mg, Single dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 600 mg, Single Dose, 1 day
[14C] BMS-813160Drug
Oral Solution, Oral, 150 mg, Single Dose, 1 day
PlaceboDrug
Oral Solution, Oral, 0 mg, Single Dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 1200 mg, Single dose, 1 day
BMS-813160Drug
Oral Solution, Oral, 2000 mg, Single Dose, 1 day
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160; Drug: Placebo |
| Arm 2 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160; Drug: Placebo |
| Arm 3 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160; Drug: Placebo |
| Arm 4 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160; Drug: Placebo |
| Arm 5 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160; Drug: Placebo |
| Arm 6 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160; Drug: Placebo |
| Arm 7 [14C] BMS-813160 | Active comparator | Not described Receives: Drug: [14C] BMS-813160 |
| Arm 8 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: Placebo; Drug: BMS-813160 |
| Arm 9 (BMS-813160 or placebo) | Active comparator | Not described Receives: Drug: BMS-813160 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
Measured: Dosing through Day 5
Secondary outcomes (4)
Pharmacokinetics of BMS-813160
Measured: 9 times after dosing
Pharmacodynamics (Plasma MCP-1)
Measured: 9 times post dose
Pharmacodynamics (Circulating monocytes)
Measured: 5 times post dose
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)
Measured: 5 times post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2010 (estimated)
- Study startFeb 2010
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accelerated Intimal HyperplasiaStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 70 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
- NCT01049165
- Sponsor's protocol ID
- CV202-001
- Status last verified
- Feb 2011
- First submitted
- 12 Jan 2010
- Last updated
- 11 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-813160 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT01049165
- Acronym / sponsor ID
- CV202-001
- Conditions
- Accelerated Intimal Hyperplasia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 14 Jan 2010 (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 and tolerability of single oral doses of BMS-813160 in healthy subjects
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| Arm 1 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160, Drug: Placebo |
| Arm 2 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160, Drug: Placebo |
| Arm 3 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160, Drug: Placebo |
| Arm 4 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160, Drug: Placebo |
| Arm 5 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160, Drug: Placebo |
| Arm 6 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160, Drug: Placebo |
| Arm 7 [14C] BMS-813160 | Active comparator | Drug: [14C] BMS-813160 |
| Arm 8 (BMS-813160 or placebo) | Active comparator | Drug: Placebo, Drug: BMS-813160 |
| Arm 9 (BMS-813160 or placebo) | Active comparator | Drug: BMS-813160 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men and women (not of child bearing potential) ages 18 to 45
- Healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
Key exclusion criteria (2 listed)
- Women of Child Bearing Potential
- Organ dysfunction or any clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
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-813160Oral Solution, Oral, 5 mg, Single dose, 1 day | Drug | Arm 1 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 20 mg, Single dose, 1 day | Drug | Arm 2 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 60 mg, Single dose, 1 day | Drug | Arm 3 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 150 mg, Single dose, 1 day | Drug | Arm 4 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 300 mg, Single dose, 1 day | Drug | Arm 5 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 600 mg, Single Dose, 1 day | Drug | Arm 6 (BMS-813160 or placebo) |
| [14C] BMS-813160Oral Solution, Oral, 150 mg, Single Dose, 1 day | Drug | Arm 7 [14C] BMS-813160 |
| PlaceboOral Solution, Oral, 0 mg, Single Dose, 1 day | Drug | Arm 1 (BMS-813160 or placebo), Arm 2 (BMS-813160 or placebo), Arm 3 (BMS-813160 or placebo), Arm 4 (BMS-813160 or placebo), Arm 5 (BMS-813160 or placebo), Arm 6 (BMS-813160 or placebo), Arm 8 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 1200 mg, Single dose, 1 day | Drug | Arm 8 (BMS-813160 or placebo) |
| BMS-813160Oral Solution, Oral, 2000 mg, Single Dose, 1 day | Drug | Arm 9 (BMS-813160 or placebo) |
Primary outcome
Safety will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events
Time frame: Dosing through Day 5
4 secondary outcomes
Pharmacokinetics of BMS-813160
Time frame: 9 times after dosing
Pharmacodynamics (Plasma MCP-1)
Time frame: 9 times post dose
Pharmacodynamics (Circulating monocytes)
Time frame: 5 times post dose
Pharmacodynamics (CCR5 phosphorylation and internalization in whole blood)
Time frame: 5 times post-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 11 Feb 2011.
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-813160 and [14C] BMS-813160 in people with Accelerated Intimal Hyperplasia, 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 2 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 11 Feb 2011. 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 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 will be assessed by clinical laboratory results, ECGs, vital signs, and reported adverse events (time frame: Dosing through Day 5). 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 11 Feb 2011.