Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00948662
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : February 25, 2013
Information provided by (Responsible Party):

July 28, 2009
July 29, 2009
February 25, 2013
September 2009
December 2010   (Final data collection date for primary outcome measure)
Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 5 days ]
  • Lab tests [ Time Frame: 4 days ]
  • Electrocardiogram (ECG) [ Time Frame: 4 days ]
  • Vital signs [ Time Frame: 4 days ]
Complete list of historical versions of study NCT00948662 on Archive Site
  • Maximum concentration (Cmax) for PF-05212377 over time. [ Time Frame: 5 days ]
  • Measurement of Area Under the curve (AUC) for PF-05212377. [ Time Frame: 5 days ]
  • Time of maximum (Tmax) concentration of PF-05212377 in plasma. [ Time Frame: 5 days ]
  • Elimination half life (t1/2) of PF-05212377. [ Time Frame: 5 days ]
Pharmacokinetic parameters (C max, AUC, tmax) [ Time Frame: 4 days ]
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Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects
Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects
This study will assess the safety and tolerability of ascending single oral doses of SAM-760 in healthy young adult and healthy elderly subjects. The secondary objectives are to provide the concentrations of SAM-760 in the blood and to evaluate the effect of a high-fat meal on the concentrations in the blood of SAM-760 administered to healthy young adult subjects, and to evaluate the effects of concomitant administration of ketoconazole on the safety and the concentrations of SAM-760 in the blood of a single dose of SAM-760 in healthy young adult subjects.
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Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Drug: SAM-760
    SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day
  • Drug: Placebo of SAM-760
    SAM-760 matching placebo capsule, single dose, 1 day,
    Other Name: Placebo
  • Drug: ketoconazole
    Ketoconazole oral tablets, 200 mg bid, 14 days
    Other Name: ketoconazole interaction arm
  • Experimental: 1
    active arm/healthy young
    Intervention: Drug: SAM-760
  • Placebo Comparator: 2
    placebo arm
    Intervention: Drug: Placebo of SAM-760
  • 3
    ketoconazole interaction evaluation
    Intervention: Drug: ketoconazole
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2010
December 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Men or women of non-childbearing potential aged 18 to 50 years inclusive (healthy young subjects) and > 65 years (healthy elderly subjects) at screening.
  • Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight >= 50 kg.

Exclusion Criteria:

  • Presence or history of any disorder that may prevent the successful completion of the study.
  • Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the investigational drug or placebo.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Study Director: Pfizer Call Center Pfizer
February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP