Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760)
NCT01159496
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Inclusion Criteria for young healthy population: Healthy male and/or female subjects of non-child bearing potential (WONCBP) between the ages of 18 and 55 years, inclusive. (Healthy is defined as no clinically relevant abnormalities identified at screening by a detailed medical history, full physical examination, including blood pressure and heart rate measurement, 12-lead ECG, neurological examination and clinical laboratory tests.)
- Inclusion Criteria for elderly population: Healthy male and/or female subjects of non-child bearing potential between the ages of 65 and 85 years, inclusive. Subjects must be in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (including blood pressure and pulse rate measurement), 12-lead ECG and clinical laboratory tests. Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis) may be enrolled if deemed medically prudent by the investigator.
- Presence or history of any disorder that may prevent the successful completion of the
study.
- Other severe acute or chronic medical or psychiatric condition or laboratory
abnormality that may increase the risk associated with study participation or
investigational product administration or may interfere with the interpretation of
study results and, in the judgment of the investigator, would make the subject
inappropriate for entry into this study.
- A score of greater than or equal to 20 on the Beck Depression Inventory and/or a
response of 1, 2, or 3 to the question related to suicide.
- History of seizure disorder and/or severe head trauma (other than a single childhood
febrile seizure).
- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
dermatologic, muscular or allergic disease or disorder (including drug allergies, but
excluding untreated, asymptomatic, seasonal allergies at time of dosing).
- Any surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the study treatment.
- Acute disease state (eg, nausea, vomiting, fever, or diarrhea) within 7 days before
study Day 1.
- History of drug abuse within 1 year before study Day 1 or a positive urine drug
screen.
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's
ability to comply with the protocol requirements.
- Consumption of more than 14 drinks/week for females or 21 drinks/week for males (1
drink = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL)
of hard liquor) within 6 months of screening.
- Subjects who smoke more than 10 cigarettes per day.
- Pregnant or nursing females; females of childbearing potential.
- Males who are unwilling to abstain from sexual intercourse or use a condom with all
child-bearing potential women for the duration of the study.
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Descriptive Information | ||||
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Brief Title ICMJE | Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760) | |||
Official Title ICMJE | A Randomized Investigator And Subject-Blind, Sponsor Open, Placebo Controlled Phase 1 Study To Characterize The Safety, Tolerability, And Pharmacokinetics Of Ascending Multiple Doses Of PF-05212377 (SAM-760) Administered Orally To Healthy Young And Elderly Subjects | |||
Brief Summary | This is a multiple ascending dose study to assess the safety, tolerability and pharmacokinetics of PF-05212377 (SAM-760) administered orally once a day for 14 days to healthy young adults and healthy elderly subjects. The study will be conducted under double-blind conditions (neither the investigator nor the subject will know if he/she has received PF-05212377 or a placebo). The Sponsor will know if the subject has received active treatment or a placebo. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double (Participant, Investigator) | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE |
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Study Arms ICMJE |
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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 | 60 | |||
Original Estimated Enrollment ICMJE | 56 | |||
Actual Study Completion Date ICMJE | December 2010 | |||
Actual Primary Completion Date | December 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 85 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01159496 | |||
Other Study ID Numbers ICMJE | B2081003 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc. | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Pfizer | |||
Verification Date | March 2011 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |