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Multiple Ascending Dose Study To Assess Safety, Tolerability And Pharmacokinetics Of PF-05212377 (SAM-760) (MAD)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT01159496
First received: July 7, 2010
Last updated: March 9, 2011
Last verified: March 2011
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: PF-05212377 (SAM-760)
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Adverse events (spontaneous and solicited). [ Time Frame: 0-24days ] [ Designated as safety issue: Yes ]
  • Change from baseline in vital signs. [ Time Frame: 0-24 days ] [ Designated as safety issue: Yes ]
  • Change from baseline in triplicate ECGs. [ Time Frame: 0-24 days ] [ Designated as safety issue: Yes ]
  • Clinical safety laboratory endpoints, including a complete blood count, reticulocytes and a full chemistry panel, including electrolytes, hepatic transaminases, and urinalysis, with microscopic analysis if dipstick analysis is positive. [ Time Frame: 0-24 days ] [ Designated as safety issue: Yes ]
  • Physical examinations and neurological examinations [ Time Frame: 0-24 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Pharmacokinetics in young adults (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2). [ Time Frame: 0-21 days ] [ Designated as safety issue: No ]
  • Pharmacokinetics in elderly subjects (Plasma concentration of PF-05212377 over time (eg, AUC, Cmax, Tmax, t1/2). [ Time Frame: 0-21 days ] [ Designated as safety issue: No ]

Enrollment: 60
Study Start Date: July 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Active Drug: PF-05212377 (SAM-760)
Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg
Other Name: SAM-760
Placebo Comparator: Placebo Drug: Placebo
Oral capsule, once daily for 14 days

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01159496

Locations
France
Pfizer Investigational Site
Rueil-Malmaison, France, 92502
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT01159496     History of Changes
Other Study ID Numbers: B2081003
Study First Received: July 7, 2010
Last Updated: March 9, 2011
Health Authority: FRANCE: Agence Francaise de Securite Sanitaire des Produits de Sante

ClinicalTrials.gov processed this record on November 20, 2014