Alzheimer DiseasePhase 1NCT00480818
Study Evaluating the Safety, Pharmacokinetics, and Pharmacodynamics of SAM-531 in Healthy Young and Elderly Subjects
A Phase 1 study testing SAM-531 in people with Alzheimer Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in France.
Trial summary
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy young adult and elderly subjects.To assess the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy young adult and elderly subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- SAM-531
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2006to Jul 2007
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men or women of nonchildbearing potential aged 18 to 45 years
- Elderly men or women aged 65 years and above as of study day 1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
- Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period.
- Elderly men or women aged 65 years and above as of study day 1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy young adult and elderly subjects.To assess the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy young adult and elderly subjects.
- Conditions
- Alzheimer Disease
- Being tested
- SAM-531
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAM-531Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability
Secondary outcomes (1)
Pharmacokinetics and pharmacodynamics
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2007 (estimated)
- Study startSep 2006
- Study completionJul 2007
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 80 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00480818
- Sponsor's protocol ID
- 3193A1-102
- Status last verified
- Dec 2007
- First submitted
- 29 May 2007
- Last updated
- 11 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Ascending Multiple Dose Study of the Safety, Pharmacokinetics (PK), and Pharmacodynamics (PD) of SAM-531 Administered Orally to Healthy Young and Elderly Subjects
- ClinicalTrials.gov ID
- NCT00480818
- Acronym / sponsor ID
- 3193A1-102
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 31 May 2007 (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.
To assess the safety and tolerability of ascending multiple oral doses of SAM-531, an investigational drug, in healthy young adult and elderly subjects.To assess the pharmacokinetics (PK) and pharmacodynamics (PD) profiles of multiple oral doses of SAM-531 in healthy young adult and elderly subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men or women of nonchildbearing potential aged 18 to 45 years
- Elderly men or women aged 65 years and above as of study day 1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.
Key exclusion criteria (5 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- Any clinically important deviation from normal limits in physical examination, vital signs, digital 12-lead ECGs, or clinical laboratory test results.
- Tobacco use or the consumption of any caffeine-containing products (e.g., coffee, tea, chocolate, or soda) or alcoholic beverages within 48 hours before study day 1, or grapefruit or grapefruit-containing products 72 hours before study day 1, and until the end of the inpatient confinement period.
- Elderly men or women aged 65 years and above as of study day 1.
- Body mass index in the range of 18 to 30 kg/m2 and body weight ≥50 kg. Body weight for elderly subjects must be ≥45 kg.
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 |
|---|---|---|
| SAM-531 | Drug | – |
Primary outcome
Safety and tolerability
1 secondary outcome
Pharmacokinetics and pharmacodynamics
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 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
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 SAM-531 in people with Alzheimer Disease, run by Wyeth is now a wholly owned subsidiary of Pfizer at 1 site in France.
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 3 inclusion and 5 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 Dec 2007. 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 France. 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 and tolerability. 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 Dec 2007.