Alzheimer DiseasePhase 1NCT01057030
Multiple Dose Japanese Bridging Study
A Phase 1 study testing BMS-708163 in people with Alzheimer Disease, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- BMS-708163
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Japanese and non-Japanese subjects
- Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
- Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
- BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
- Men ages 20 to 45 years
Who cannot join
- Serum creatinine values above the normal range
- Urine protein or blood levels above the normal range
- Liver function tests above the normal range
- TSH, free T3, or free T4 outside the normal range
- Amylase or lipase levels above the normal range
- Positive Fecal Immunochemical Test (FIT™)
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group
Glendale, California, 91206
About this study
Official title: Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects
The purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects
- Conditions
- Alzheimer Disease
- Being tested
- BMS-708163, Placebo
- 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
Also called (GAMMA SECRETASE inhibitor)
Capsules, Oral, 125 mg, once daily, 14 days
PlaceboDrug
Capsules, Oral, 0 mg, once daily, 14 days
| Study group | Role | What they receive |
|---|---|---|
| A1 (BMS-708163) | Active comparator | Healthy Japanese Subjects Receives: Drug: BMS-708163 |
| A2 (Placebo) | Placebo comparator | Healthy Japanese Subjects Receives: Drug: Placebo |
| B1 (BMS-708163) | Active comparator | Healthy Non-Japanese Subjects Receives: Drug: BMS-708163 |
| B2 (Placebo) | Placebo comparator | Healthy Non-Japanese Subjects Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Measured: Every day for 28 days
Secondary outcomes (1)
BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))
Measured: Days 1, 7, and 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 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
- NCT01057030
- Sponsor's protocol ID
- CN156-038
- Status last verified
- Jun 2010
- First submitted
- 26 Jan 2010
- Last updated
- 25 Jan 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of BMS-708163 125 mg in Healthy Japanese and Non-Japanese Subjects
- ClinicalTrials.gov ID
- NCT01057030
- Acronym / sponsor ID
- CN156-038
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 27 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 purpose of this study is to assess the safety and tolerability of multiple oral daily doses of BMS-708163 in healthy young male subjects
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A1 (BMS-708163) | Active comparator | Drug: BMS-708163Healthy Japanese Subjects |
| A2 (Placebo) | Placebo comparator | Drug: PlaceboHealthy Japanese Subjects |
| B1 (BMS-708163) | Active comparator | Drug: BMS-708163Healthy Non-Japanese Subjects |
| B2 (Placebo) | Placebo comparator | Drug: PlaceboHealthy Non-Japanese Subjects |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy Japanese and non-Japanese subjects
- Japanese subjects must be first generation Japanese and must demonstrate both maternal and paternal Japanese ancestry
- Non-Japanese subjects must not be of Japanese or Asian descent, ie, neither parent nor grandparent was born in Japan or in any Asian country
- BMI of 19 to 25 kg/m², for Japanese and non-Japanese subjects
- Men ages 20 to 45 years
Key exclusion criteria (6 listed)
- Serum creatinine values above the normal range
- Urine protein or blood levels above the normal range
- Liver function tests above the normal range
- TSH, free T3, or free T4 outside the normal range
- Amylase or lipase levels above the normal range
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-708163Also: (GAMMA SECRETASE inhibitor)Capsules, Oral, 125 mg, once daily, 14 days | Drug | A1 (BMS-708163), B1 (BMS-708163) |
| PlaceboCapsules, Oral, 0 mg, once daily, 14 days | Drug | A2 (Placebo), B2 (Placebo) |
Primary outcome
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs)
Time frame: Every day for 28 days
1 secondary outcome
BMS-708163 pharmacokinetic parameters (Cmax, Cmin, Ctrough, Tmax, AUC(TAU), AI, and CLT/F and T-HALF (only following Day 14 dose))
Time frame: Days 1, 7, and 14
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 25 Jan 2011.
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Aging
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 Disease, 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 5 inclusion and 6 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 25 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. Some participants in this study may receive a placebo. 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?
BMS-708163 or placebo in Japanese and non-Japanese: Safety and tolerability (AE's, ECG, vital signs, safety labs) (time frame: Every day for 28 days). 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 25 Jan 2011.