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

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ClinicalTrials.gov Identifier: NCT00948662
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : February 25, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: SAM-760 Drug: Placebo of SAM-760 Drug: ketoconazole Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects
Study Start Date : September 2009
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 1
active arm/healthy young
Drug: SAM-760
SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day

Placebo Comparator: 2
placebo arm
Drug: Placebo of SAM-760
SAM-760 matching placebo capsule, single dose, 1 day,
Other Name: Placebo

3
ketoconazole interaction evaluation
Drug: ketoconazole
Ketoconazole oral tablets, 200 mg bid, 14 days
Other Name: ketoconazole interaction arm




Primary Outcome Measures :
  1. Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: 5 days ]

Secondary Outcome Measures :
  1. Maximum concentration (Cmax) for PF-05212377 over time. [ Time Frame: 5 days ]
  2. Measurement of Area Under the curve (AUC) for PF-05212377. [ Time Frame: 5 days ]
  3. Time of maximum (Tmax) concentration of PF-05212377 in plasma. [ Time Frame: 5 days ]
  4. Elimination half life (t1/2) of PF-05212377. [ Time Frame: 5 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948662


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

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00948662     History of Changes
Obsolete Identifiers: NCT01298453
Other Study ID Numbers: 3276A1-1000
B2081001
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: February 25, 2013
Last Verified: February 2013

Keywords provided by Pfizer:
Safety
tolerability
ascending single doses
healthy subjects

Additional relevant MeSH terms:
Ketoconazole
Antifungal Agents
Anti-Infective Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors