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

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: SAM-760; Drug: ketoconazole; Drug: Placebo of SAM-760

Study type: Interventional

Funder types: Industry

Identifiers

NCT00948662

3276A1-1000

B2081001

Details and patient eligibility

About

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.

Enrollment: 124 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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124 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

active arm/healthy young

Treatment:

Drug: SAM-760

2

Placebo Comparator group

Description:

placebo arm

Treatment:

Drug: Placebo of SAM-760

3

Other group

Description:

ketoconazole interaction evaluation

Treatment:

Drug: ketoconazole