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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00948662
First received: July 28, 2009
Last updated: February 21, 2013
Last verified: February 2013

July 28, 2009
February 21, 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 ] [ Designated as safety issue: Yes ]
  • Vital signs [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Lab tests [ Time Frame: 4 days ] [ Designated as safety issue: No ]
  • Electrocardiogram (ECG) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00948662 on ClinicalTrials.gov Archive Site
  • Maximum concentration (Cmax) for PF-05212377 over time. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Measurement of Area Under the curve (AUC) for PF-05212377. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Time of maximum (Tmax) concentration of PF-05212377 in plasma. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Elimination half life (t1/2) of PF-05212377. [ Time Frame: 5 days ] [ Designated as safety issue: No ]
Pharmacokinetic parameters (C max, AUC, tmax) [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
    Other Name: SAM-760
  • 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.
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00948662
3276A1-1000, B2081001
No
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