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Completed

NCT Number: NCT00948662

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

Conditions

Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site

Rueil-Malmaison, France, 92502

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

SAM-760

Drug

SAM-760 capsule, 0.25, 0.75, 2.25, 5, 10, 15, 20, 25, 35 and 45mg, single dose, 1 day

Placebo of SAM-760

Drug

SAM-760 matching placebo capsule, single dose, 1 day,

Other names: Placebo

Ketoconazole

Drug

Ketoconazole oral tablets, 200 mg bid, 14 days

Other names: ketoconazole interaction arm

Primary outcomes

  1. Number of participants with adverse events as a measure of safety and tolerability.

    Time frame: 5 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Registry information

Official study title

Ascending Single Dose Study Of The Safety, Tolerability And Pharmacokinetics Of SAM-760 Administered Orally To Healthy Young And Healthy Elderly Subjects

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 29, 2009
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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