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

Last updated on May 11, 2018

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Study Location
Pfizer Investigational Site
Rueil Malmaison, , 92502 France
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
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 surgical or medical condition that may interfere with the absorption,
distribution, metabolism, or excretion of the investigational drug or placebo.

NCT00948662
Pfizer
Completed
Study Evaluating The Safety And Tolerability Of Administration Of Single Oral Doses Of SAM-760 To Healthy Subjects

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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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Healthy
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
124
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)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT00948662
3276A1-1000
B2081001
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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