Alzheimer DiseasePhase 1NCT00860275
Drug-Drug Interaction (DDI) w/Ketoconazole or Fluconazole
A Phase 1 study testing BMS-708163, BMS-708163 + Ketoconazole and Ketoconazole in people with Alzheimer Disease, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- BMS-708163, BMS-708163 + Ketoconazole and Ketoconazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
Who cannot join
- Premenopausal women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
The purpose of the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163
- Conditions
- Alzheimer Disease
- Being tested
- BMS-708163, BMS-708163 + Ketoconazole, Ketoconazole, Fluconazole, BMS-708163 + Fluconazole
- 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
Capsule, Oral, 50 mg, once, Day 1
BMS-708163 + KetoconazoleDrug
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day
KetoconazoleDrug
Tablet, Oral, 400 mg, daily, 16 days
FluconazoleDrug
Tablet, Oral, 1 day 400 mg then 3 days 200 mg
BMS-708163 + FluconazoleDrug
(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days
| Study group | Role | What they receive |
|---|---|---|
| BMS-708163 / Ketoconazole | Active comparator | Not described Receives: Drug: BMS-708163; Drug: BMS-708163 + Ketoconazole; Drug: Ketoconazole |
| BMS-708163 / Fluconazole | Active comparator | Not described Receives: Drug: BMS-708163; Drug: Fluconazole; Drug: BMS-708163 + Fluconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of BMS-708163
Measured: Within 14 days after dose
Secondary outcomes (1)
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole
Measured: During the entire study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2009
- Study completionJun 2009
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00860275
- Sponsor's protocol ID
- CN156-019
- Status last verified
- Jul 2009
- First submitted
- 11 Mar 2009
- 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
- A Study of the Effect of Concomitant Administration of Ketoconazole or Fluconazole on the Pharmacokinetics of BMS-708163 in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00860275
- Acronym / sponsor ID
- CN156-019
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 Mar 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 the study is to determine if the concomitant administration of either ketoconazole or fluconazole with BMS-708163 will affect the PK of BMS-708163 and to assess safety and tolerability of BMS-708163
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BMS-708163 / Ketoconazole | Active comparator | Drug: BMS-708163, Drug: BMS-708163 + Ketoconazole, Drug: Ketoconazole |
| BMS-708163 / Fluconazole | Active comparator | Drug: BMS-708163, Drug: Fluconazole, Drug: BMS-708163 + Fluconazole |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male and postmenopausal female subjects 18-55 yrs old inclusive
Key exclusion criteria (1 listed)
- Premenopausal 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-708163Capsule, Oral, 50 mg, once, Day 1 | Drug | BMS-708163 / Fluconazole, BMS-708163 / Ketoconazole |
| BMS-708163 + Ketoconazole(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day Day 12 (Ketoconazole) - Tablet, Oral, 400 mg, daily, 1 day | Drug | BMS-708163 / Ketoconazole |
| KetoconazoleTablet, Oral, 400 mg, daily, 16 days | Drug | BMS-708163 / Ketoconazole |
| FluconazoleTablet, Oral, 1 day 400 mg then 3 days 200 mg | Drug | BMS-708163 / Fluconazole |
| BMS-708163 + Fluconazole(BMS-708163) - Capsule, Oral, 50 mg, daily, 1 day (Day 12) (Fluconazole) - Tablet, Oral, 200 mg, daily, 13 days | Drug | BMS-708163 / Fluconazole |
Primary outcome
PK profile of BMS-708163
Time frame: Within 14 days after dose
1 secondary outcome
Safety and tolerability of BMS-708163 when administered alone and with either ketoconazole or fluconazole
Time frame: During the entire study period
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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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, BMS-708163 + Ketoconazole and Ketoconazole 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 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 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. 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?
PK profile of BMS-708163 (time frame: Within 14 days after 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 25 Jan 2011.