Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects
NCT00906191
Last updated date
ABOUT THIS STUDY
The objective of this study is to investigate how quickly and to what extent the 14-Carbon
labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body
after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is
radioactive, this enables the compound to be traced in blood, urine and feces.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alzheimer Disease
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-50 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- Men aged 18 to 50 years inclusive at screening
- Healthy as determined by the investigator on the basis of screening evaluations
Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- Presence or history of any disorder that may prevent the successful completion of the
study.
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal,
endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
Alzheimer DiseaseLipitor as a Treatment for Alzheimer's Disease
NCT00024531
- Sun City, Arizona
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer DiseaseStudy Evaluating The Efficacy And Safety Of Bapineuzumab In Alzheimer Disease Patients
NCT00667810
- Birmingham, Alabama
- Goodyear, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Costa Mesa, California
- Encino, California
- Fresno, California
- Laguna Hills, California
- Laguna Hills, California
- Loma Linda, California
- Loma Linda, California
- Long Beach, California
- Los Alamitos, California
- Newport Beach, California
- San Diego, California
- San Diego, California
- San Diego, California
- San Diego, California
- San Diego, California
- San Diego, California
- San Francisco, California
- Boulder, Colorado
- Boulder, Colorado
- Denver, Colorado
- Danbury, Connecticut
- Fairfield, Connecticut
- Greenwich, Connecticut
- Greenwich, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- Norwalk, Connecticut
- Waterbury, Connecticut
- Atlantis, Florida
- Atlantis, Florida
- Bradenton, Florida
- Deerfield Beach, Florida
- Delray Beach, Florida
- Fort Lauderdale, Florida
- Hallandale Beach, Florida
- Ocala, Florida
- Ocala, Florida
- Orlando, Florida
- Palm Beach Gardens, Florida
- Port Charlotte, Florida
- Sarasota, Florida
- Sun City, Florida
- Tampa, Florida
- West Palm Beach, Florida
- Atlanta, Georgia
- Columbus, Georgia
- Columbus, Georgia
- Decatur, Georgia
- Decatur, Georgia
- Lawerenceville, Georgia
- Lawrenceville, Georgia
- Elk Grove Village, Illinois
- Elk Grove Village, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Peoria, Illinois
- Springfield, Illinois
- Springfield, Illinois
- Elkhart, Indiana
- Mishawaka, Indiana
- Wichita, Kansas
- Wichitia, Kansas
- Paducah, Kentucky
- Paducah, Kentucky
- Lake Charles, Louisiana
- New Orleans, Louisiana
- Shreveport, Louisiana
- Bethesda, Maryland
- Rockville, Maryland
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Haverhill, Massachusetts
- Newton, Massachusetts
- Springfield, Massachusetts
- Ann Arbor, Michigan
- Ann Arbor, Michigan
- Ann Arbor, Michigan
- East Lansing, Michigan
- Lansing, Michigan
- Flowood, Mississippi
- Flowood, Mississippi
- Hattiesburg, Mississippi
- Kansas City, Missouri
- Great Falls, Montana
- Great Falls, Montana
- Berlin, New Jersey
- Eatontown, New Jersey
- Manchester, New Jersey
- Toms River, New Jersey
- Brewster, New York
- Liverpool, New York
- Rochester, New York
- Rochester, New York
- Asheville, North Carolina
- Charlotte, North Carolina
- Hickory, North Carolina
- Hickory, North Carolina
- Raleigh, North Carolina
- Raleigh, North Carolina
- Raleigh, North Carolina
- Raleigh, North Carolina
- Columbus, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Columbus, Ohio
- Toledo, Ohio
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Oklahoma City, Oklahoma
- Portland, Oregon
- Abington, Pennsylvania
- Abington, Pennsylvania
- Jenkintown, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Pittsburgh, Pennsylvania
- Willow Grove, Pennsylvania
- East Providence, Rhode Island
- Pawtucket, Rhode Island
- Providence, Rhode Island
- Charleston, South Carolina
- Charleston, South Carolina
- Greer, South Carolina
- North Charleston, South Carolina
- Cordova, Tennessee
- Austin, Texas
- Austin, Texas
- Dallas, Texas
- Fort Worth, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- Wichita Falls, Texas
- Bennington, Vermont
- Bennington, Vermont
- Charlottesville, Virginia
- Charlottesville, Virginia
- Charlottesville, Virginia
- Bothell, Washington
- Seattle, Washington
- Buenos Aires,
- Buenos Aires,
- Gosford, New South Wales
- Hornsby, New South Wales
- Woodville South, South Australia
- Ballarat, Victoria
- West Heidelberg, Victoria
- Nedlands, Western Australia
- Nedlands, Western Australia
- Adelaide SA,
- Antwerpen,
- Brugge,
- Bruxelles,
- Edegem,
- Leuven,
- Roeselare,
- North York, Ontario
- Ottawa, Ontario
- Toronto, Ontario
- Toronto, Ontario
- L'Ancienne-Lorette, Quebec
- Montreal, Quebec
- Montreal, Quebec
- Sherbrooke, Quebec
- Quebec,
- Santiago,
- Santiago,
- Zagreb,
- Zagreb,
- Kuopio,
- Turku,
- Rennes, Cedex
- Amiens,
- Bron,
- Caen,
- Colmar,
- Dijon,
- Lille,
- Marseille,
- Marseille,
- Montpellier,
- Nantes - Saint Herblain,
- Nice,
- Paris Cedex 13,
- Paris,
- Poitiers,
- Reims,
- Rouen,
- Toulouse,
- Toulouse,
- Berlin,
- Bochum,
- Offenburg,
- Regensburg,
- Ancona,
- Brescia,
- Catania,
- Chieti,
- Firenze,
- Milano,
- Milano,
- Milano,
- Monza,
- Monza,
- Roma,
- Roma,
- Siena,
- Nagoya, Aichi,
- Ota-ku, Tokyo
- Aichi,
- Chiba,
- Chiba,
- Chiba,
- Fukuoka,
- Gunma,
- Gunma,
- Gunma,
- Hiroshima,
- Hyogo,
- Hyogo,
- Hyogo,
- Iwate,
- Kagawa,
- Kanagawa,
- Kanagawa,
- Kanagawa,
- Kyoto,
- Kyoto,
- Kyoto,
- Nagano,
- Niigata,
- Okayama,
- Okayama,
- Osaka,
- Osaka,
- Osaka,
- Shizuoka,
- Tokyo,
- Tokyo,
- Tokyo,
- Tokyo,
- Tokyo,
- Seongnam-si, Gyeonggi-do
- Seoul,
- Monterrey, Nuevo León
- Aguascalientes,
- 's-Hertogenbosch,
- Amsterdam,
- Breda,
- Eindhoven,
- Haarlem,
- Leeuwarden,
- s. Hertogenbosch,
- Auckland, NZ
- Christchurch,
- Bydgoszcz,
- Kielce,
- Krakow,
- Poznan,
- Warszawa,
- Warszawa,
- Amadora,
- Coimbra,
- Lisboa,
- Kazan,
- Nizhny Novgorod,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Saint-Petersburg,
- Novi Sad, Vojvodina
- Belgrade,
- Beograd,
- Kragujevac,
- Bratislava,
- Bratislava,
- Bratislava,
- Bratislava,
- Martin,
- Michalovce,
- Rimavska Sobota,
- Zilina,
- Johannesburg, Gauteng
- Johannesburg, Gauteng
- Pretoria, Gauteng
- Durban, Kwa Zulu Natal
- Panorama, Western Cape
- Elche, Alicante
- Terrassa, Barcelona
- Plasencia, Caceres
- Palma de Mallorca, Islas Baleares
- Palma de Mallorca, Islas Baleares
- Baracaldo,
- Barcelona,
- Barcelona,
- Barcelona,
- Barcelona,
- Burgos,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Murcia,
- Malmo,
- Uppsala,
- Uppsala,
- Uppsala,
- Basel, BS
- Les Acacias, GE
- Lausanne, VD
- Thonex-Geneva,
- Blackpool, Lancashire
- Bradford, West Yorkshire
- Brighton,
- Glasgow,
- London,
- London,
- Newcastle upon Tyne,
- Northampton,
- Penarth,
- Sheffield,
- Sheffield,
- Swindon,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Alzheimer DiseaseStudy Evaluating PAZ-417 in Cerebrospinal Fluid in Subjects With Alzheimer's Disease
NCT00739037
- Glendale, California
ALL GENDERS
55 Years+
years
MULTIPLE SITES
Alzheimer DiseaseStudy Evaluating the Safety and Efficacy of Bapineuzumab in Alzheimer Disease Patients
NCT00676143
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Birmingham, Alabama
- Goodyear, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Phoenix, Arizona
- Little Rock, Arkansas
- Carson, California
- Long Beach, California
- San Francisco, California
- Boulder, Colorado
- Boulder, Colorado
- Denver, Colorado
- Fairfield, Connecticut
- Greenwich, Connecticut
- Greenwich, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- New Haven, Connecticut
- Norwalk, Connecticut
- Atlantis, Florida
- Atlantis, Florida
- Atlantis, Florida
- Delray Beach, Florida
- Orlando, Florida
- Palm Beach Gardens, Florida
- Port Charlotte, Florida
- Sarasota, Florida
- Tampa, Florida
- Decatur, Georgia
- Decatur, Georgia
- Lawrenceville, Georgia
- Elk Grove Village, Illinois
- Springfield, Illinois
- Springfield, Illinois
- Kansas City, Kansas
- Lake Charles, Louisiana
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Boston, Massachusetts
- Dartmouth, Massachusetts
- Pittsfield, Massachusetts
- Springfield, Massachusetts
- Ann Arbor,, Michigan
- Ann Arbor, Michigan
- Ann Arbor, Michigan
- Ann Arbor, Michigan
- East Lansing, Michigan
- Hattiesburg, Mississippi
- Kansas City, Missouri
- Eatontown, New Jersey
- Edison, New Jersey
- Manchester, New Jersey
- Liverpool, New York
- Raleigh, North Carolina
- Raleigh, North Carolina
- Raleigh, North Carolina
- Raleigh, North Carolina
- Columbs, Ohio
- Columbs, Ohio
- Columbus, Ohio
- Portland, Oregon
- Portland, Oregon
- Portland, Oregon
- Portland, Oregon
- Silverton, Oregon
- Abington, Pennsylvania
- Abington, Pennsylvania
- Abington, Pennsylvania
- Flourtown, Pennsylvania
- Jenkintown, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Philadelphia, Pennsylvania
- Willow Grove, Pennsylvania
- East Providence, Rhode Island
- Pawtucket, Rhode Island
- Providence, Rhode Island
- Charleston, South Carolina
- Charleston, South Carolina
- Charleston, South Carolina
- North Charleston, South Carolina
- Dallas, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- San Antonio, Texas
- Bennington, Vermont
- Bennington, Vermont
- Madison, Wisconsin
- Madison, Wisconsin
- Madison, Wisconsin
- Madison, Wisconsin
- Madison, Wisconsin
- Buenos Aires,
- Buenos Aires,
- Buenos Aires,
- Cordoba,
- Gosford, New South Wales
- Gosford, New South Wales
- Hornsby, New South Wales
- Adelaide, South Australia
- Woodville South, South Australia
- Ballarat, Victoria
- West Heidelberg, Victoria
- Nedlands, Western Australia
- Nedlands, Western Australia
- Graz,
- Klagenfurt,
- Wien,
- Wien,
- Wien,
- Antwerpen,
- Brugge,
- Brussels,
- Edegem,
- Leuven,
- Roeselare,
- Santiago,
- Santiago,
- Zagreb,
- Kuopio,
- Turku,
- Bordeaux Cedex,
- Bron,
- Caen,
- Caen,
- Colmar,
- Dijon,
- Lille,
- Marseille,
- Montpellier,
- Nantes - Saint Herblain,
- Nice,
- Nice,
- Paris,
- Paris,
- Poitiers,
- Reims,
- Rennes Cedex,
- Rouen,
- Toulouse,
- Toulouse,
- Berlin,
- Bochum,
- Dresden,
- Freiburg,
- Offenburg,
- Ulm,
- Ancona,
- Ancona,
- Brescia,
- Catania,
- Catania,
- Chieti,
- Milano,
- Monza,
- Roma,
- Roma,
- Siena,
- Nagoya, Aichi,
- Kiyose, Tokyo
- Aichi,
- Chiba,
- Chiba,
- Chiba,
- Fukuoka,
- Gunma,
- Gunma,
- Gunma,
- Hiroshima,
- Hyogo,
- Hyogo,
- Hyogo,
- Iwate,
- Kagawa,
- Kanagawa,
- Kanagawa,
- Kanagawa,
- Kyoto,
- Kyoto,
- Kyoto,
- Nagano,
- Niigata,
- Okayama,
- Okayama,
- Osaka,
- Osaka,
- Osaka,
- Shizuoka,
- Tokyo,
- Tokyo,
- Tokyo,
- Tokyo,
- Tokyo,
- Monterrey, Nuevo León
- Aguascalientes,
- Breda, Noord Brabant
- Hilversum, Noord Holland
- Haarlem, The Netherlands
- 's-Hertogenbosch,
- Alkmaar,
- Amsterdam,
- Eindhoven,
- Leeuwarden,
- Rotterdam,
- Auckland, NZ
- Christchurch,
- Bydgoszcz,
- Krakow,
- Poznan,
- Warszawa,
- Warszawa,
- Amadora,
- Coimbra,
- Lisboa,
- Belgrade,
- Kragujevac,
- Novi Sad,
- Sremska Kamenica,
- Sremska Kamenica,
- Bratislava,
- Bratislava,
- Michalovce,
- Rimavska Sobota,
- Johannesburg, Gauteng
- Johannesburg, Gauteng
- Pretoria, Gauteng
- Durban, Kwa Zulu Natal
- Bellville, Western Cape
- Panorama, Western Cape
- Elche, Alicante
- Terrassa, Barcelona
- Plasencia, Caceres
- Palma de Mallorca, Islas Baleares
- Palma de Mallorca, Islas Baleares
- San Sebastian, Pais Vasco
- Baracaldo, Vizcalla
- Barcelona,
- Barcelona,
- Barcelona,
- Barcelona,
- Burgos,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Madrid,
- Murcia,
- Malmo,
- Uppsala,
- Uppsala,
- Uppsala,
- Basel, BS
- Les Acacias, GE
- Lausanne, VD
- Thonex-Geneva,
- Blackpool, Lancashire
- Trafford Park, Manchester
- Bradford,
- Brighton,
- Glasgow,
- London,
- London,
- Newcastle upon Tyne,
- Northampton,
- Penarth,
- Sheffield,
- Sheffield,
- Swindon,
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| Brief Title ICMJE | Study Evaluating How Quickly And To What Extent The 14-Carbon-SAM-531 Is Absorbed/Converted/Eliminated In Male Subjects | |||
| Official Title ICMJE | An Open-Label, Single-Dose, Nonrandomized Study Of The Mass Balance And Metabolic Disposition Of Orally Administered 14C-Labeled SAM-531 In Healthy Male Subjects | |||
| Brief Summary | The objective of this study is to investigate how quickly and to what extent the 14-Carbon labeled SAM-531 is absorbed into the bloodstream, converted and eliminated from the body after oral administration in healthy male subjects. As 14-Carbon labeled SAM-531 is radioactive, this enables the compound to be traced in blood, urine and feces. | |||
| Detailed Description | Not Provided | |||
| Study Type ICMJE | Interventional | |||
| Study Phase ICMJE | Phase 1 | |||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research | |||
| Condition ICMJE | Alzheimer Disease | |||
| Intervention ICMJE | Drug: SAM-531 | |||
| Study Arms ICMJE | Experimental: 1
Single oral dose Intervention: Drug: SAM-531 | |||
| Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
| Recruitment Information | ||||
| Recruitment Status ICMJE | Completed | |||
| Actual Enrollment ICMJE | 6 | |||
| Original Estimated Enrollment ICMJE | Same as current | |||
| Actual Study Completion Date ICMJE | August 2009 | |||
| Actual Primary Completion Date | August 2009 (Final data collection date for primary outcome measure) | |||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
| Sex/Gender ICMJE |
| |||
| Ages ICMJE | 18 Years to 50 Years (Adult) | |||
| Accepts Healthy Volunteers ICMJE | Yes | |||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
| Listed Location Countries ICMJE | Netherlands | |||
| Removed Location Countries | ||||
| Administrative Information | ||||
| NCT Number ICMJE | NCT00906191 | |||
| Other Study ID Numbers ICMJE | 3193A1-1114 | |||
| Has Data Monitoring Committee | No | |||
| U.S. FDA-regulated Product | Not Provided | |||
| IPD Sharing Statement ICMJE | Not Provided | |||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | |||
| Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Collaborators ICMJE | Not Provided | |||
| Investigators ICMJE |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | August 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP | ||||