AtherosclerosisPhase 1NCT00836602
Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
A Phase 1 study testing BMS-779788 in people with Atherosclerosis, run by Bristol-Myers Squibb at 1 site in Australia.
Trial summary
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 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
- Atherosclerosis
- What is being tested?
- BMS-779788
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2009to Jul 2009
- 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
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
The primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 in healthy subjects
- Conditions
- Atherosclerosis
- Being tested
- BMS-779788, Placebo
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-779788Drug
Oral Solution, Oral, 1 mg, Once daily, 7 days
BMS-779788Drug
Oral Solution, Oral, 2 mg, Once daily, 7 days
BMS-779788Drug
Oral Solution, Oral, <= 4 mg, Once daily, 7 days
PlaceboDrug
Oral Solution, Oral, 0 mg, Once daily, 7 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-779788 or Placebo (Arm 1) | Active comparator | Not described Receives: Drug: BMS-779788; Drug: Placebo |
| BMS-779788 or Placebo (Arm 2) | Active comparator | Not described Receives: Drug: BMS-779788; Drug: Placebo |
| BMS-779788 or Placebo (Arm 3) | Active comparator | Not described Receives: Drug: BMS-779788; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Measured: 8 times within 27 days of the first dose
Secondary outcomes (1)
Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
Measured: After each dose panel
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionJul 2009
- Study completionJul 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 AtherosclerosisStudies 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
- 25 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
- NCT00836602
- Sponsor's protocol ID
- CV197-002
- Status last verified
- Aug 2009
- First submitted
- 30 Jan 2009
- Last updated
- 23 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Richartz J, Yam SC, Zhan N, Schepers M, Tiane A, Mulder MT, Wens I, Vanmierlo T. Liver X receptors: A therapeutic target in demyelinating disorders. Pharmacol Res. 2025 Sep;219:107861. doi: 10.1016/j.phrs.2025.107861. Epub 2025 Jul 20.
PubMed 40695410
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Placebo-Controlled, Ascending, Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-779788 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00836602
- Acronym / sponsor ID
- CV197-002
- Conditions
- Atherosclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Feb 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 4 Feb 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 primary purpose of this study is to evaluate the safety and tolerability of multiple oral doses of BMS-779788 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
- 3
| Arm | Type | Receives |
|---|---|---|
| BMS-779788 or Placebo (Arm 1) | Active comparator | Drug: BMS-779788, Drug: Placebo |
| BMS-779788 or Placebo (Arm 2) | Active comparator | Drug: BMS-779788, Drug: Placebo |
| BMS-779788 or Placebo (Arm 3) | Active comparator | Drug: BMS-779788, Drug: Placebo |
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
- Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or 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-779788Oral Solution, Oral, 1 mg, Once daily, 7 days | Drug | BMS-779788 or Placebo (Arm 1) |
| BMS-779788Oral Solution, Oral, 2 mg, Once daily, 7 days | Drug | BMS-779788 or Placebo (Arm 2) |
| BMS-779788Oral Solution, Oral, <= 4 mg, Once daily, 7 days | Drug | BMS-779788 or Placebo (Arm 3) |
| PlaceboOral Solution, Oral, 0 mg, Once daily, 7 days | Drug | BMS-779788 or Placebo (Arm 1), BMS-779788 or Placebo (Arm 2), BMS-779788 or Placebo (Arm 3) |
Primary outcome
Safety assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests
Time frame: 8 times within 27 days of the first dose
1 secondary outcome
Pharmacokinetics (Target gene expression of BMS-779788 in whole blood and adipose tissue and corresponding serum markers)
Time frame: After each dose panel
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 23 Feb 2011.
- Derived from this study: PubMed 40695410Richartz J, Yam SC, Zhan N, Schepers M, Tiane A, Mulder MT, Wens I, Vanmierlo T. Liver X receptors: A therapeutic target in demyelinating disorders. Pharmacol Res. 2025 Sep;219:107861. doi: 10.1016/j.phrs.2025.107861. Epub 2025 Jul 20.
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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-779788 in people with Atherosclerosis, run by Bristol-Myers Squibb at 1 site in Australia.
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 23 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 Australia. 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 assessment, including medical review of adverse event reports and the results of vital sign measurements, ECGs, physical examinations, and clinical laboratory tests (time frame: 8 times within 27 days of the first 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 NCT00836602, 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 23 Feb 2011.