Alzheimer's DiseasePhase 1NCT00901498
Relative Bioavailability Study of Four Experimental Formulations for Alzheimer's Disease
A Phase 1 study testing BMS-708163 in people with Alzheimer's Disease and Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Healthy
- What is being tested?
- BMS-708163
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- May 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
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Young healthy male subjects
Who cannot join
- Women
Trial locations and contacts
1 site in 1 country.
United States1 site
Mds Pharma Services (Us) Inc.
Neptune City, New Jersey, 07753
About this study
Official title: A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects
The purpose of this study is to assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.
- Conditions
- Alzheimer's Disease, Healthy
- Being tested
- BMS-708163
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-708163Drug
Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators.
BMS-708163Drug
Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings
BMS-708163Drug
Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings
BMS-708163Drug
Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings
BMS-708163Drug
Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings
| Study group | Role | What they receive |
|---|---|---|
| Treatment A (Reference) | Experimental | Not described Receives: Drug: BMS-708163 |
| Treatment B | Active comparator | Not described Receives: Drug: BMS-708163 |
| Treatment C | Active comparator | Not described Receives: Drug: BMS-708163 |
| Treatment D | Active comparator | Not described Receives: Drug: BMS-708163 |
| Treatment E | Active comparator | Not described Receives: Drug: BMS-708163 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation
Measured: Day 1, up to 3 weeks
Secondary outcomes (4)
Safety: Adverse Events
Measured: Day 1, up to 3 weeks
Safety: Vital Signs
Measured: Screening, Day 1 and Day 4 of each period
Safety: ECGs
Measured: Screening, Day 1 of each period, up to 3 weeks
Safety: Clinical Lab Tests
Measured: Screening, Day -1 of each period, Day 1, up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2009 (estimated)
- Study startMay 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.
- Other trials for Alzheimer's DiseaseStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 36 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
- NCT00901498
- Sponsor's protocol ID
- CN156-004
- Status last verified
- Aug 2009
- First submitted
- 5 May 2009
- Last updated
- 7 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Bioavailability Study of Four Experimental BMS-708163 Formulations Relative to Solubilized Capsule Formulation in Healthy Young Male Subjects
- ClinicalTrials.gov ID
- NCT00901498
- Acronym / sponsor ID
- CN156-004
- Conditions
- Alzheimer's Disease, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 13 May 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 assess the bioavailability of four experimental formulations relative to the current reference formulation used in the Phase 2 study.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Treatment A (Reference) | Experimental | Drug: BMS-708163 |
| Treatment B | Active comparator | Drug: BMS-708163 |
| Treatment C | Active comparator | Drug: BMS-708163 |
| Treatment D | Active comparator | Drug: BMS-708163 |
| Treatment E | Active comparator | Drug: BMS-708163 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Young healthy male subjects
Key exclusion criteria (1 listed)
- Women
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-708163Oral, 25 mg Hard Gelatin Capsule, Size #2, 150 mg, Once per period of 3, 7 days between dosings. Will be compared with any 2 comparators. | Drug | Treatment A (Reference) |
| BMS-708163Oral, 75 mg Tablet Formulation 1, 150 mg, Once per period of 3, 7 days between dosings | Drug | Treatment B |
| BMS-708163Oral, 50 mg Hard Gelatin Capsule, Size #0, 150 mg, Once per period of 3, 7 days between dosings | Drug | Treatment C |
| BMS-708163Oral, 75 mg Soft Gelatin Capsule, 150 mg, Once per period of 3, 7 days between dosings | Drug | Treatment D |
| BMS-708163Oral, 75 mg Tablet Formulation 2, 150 mg, Once per period of 3, 7 days between dosings | Drug | Treatment E |
Primary outcome
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation
Time frame: Day 1, up to 3 weeks
4 secondary outcomes
Safety: Adverse Events
Time frame: Day 1, up to 3 weeks
Safety: Vital Signs
Time frame: Screening, Day 1 and Day 4 of each period
Safety: ECGs
Time frame: Screening, Day 1 of each period, up to 3 weeks
Safety: Clinical Lab Tests
Time frame: Screening, Day -1 of each period, Day 1, up to 3 weeks
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 7 Jan 2011.
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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-708163 in people with Alzheimer's Disease and Healthy, 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 1 inclusion and 1 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 7 Jan 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?
To assess the bioavailability of 4 experimental formulations relative to the current reference formulation (time frame: Day 1, up to 3 weeks). 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 7 Jan 2011.