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
  Purpose

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 Intervention Phase
Healthy
Drug: SAM-760
Drug: Placebo of SAM-760
Drug: ketoconazole
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Secondary Outcome Measures:
  • 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 ]

Enrollment: 124
Study Start Date: September 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Name: SAM-760
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  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: NCT00948662

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: Pfizer
ClinicalTrials.gov Identifier: NCT00948662     History of Changes
Obsolete Identifiers: NCT01298453
Other Study ID Numbers: 3276A1-1000, B2081001
Study First Received: July 28, 2009
Last Updated: February 21, 2013
Health Authority: United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Ketoconazole
14-alpha Demethylase Inhibitors
Anti-Infective Agents
Antifungal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014