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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

active arm/healthy young

Group Type EXPERIMENTAL

SAM-760

Intervention Type DRUG

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

2

placebo arm

Group Type PLACEBO_COMPARATOR

Placebo of SAM-760

Intervention Type DRUG

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

3

ketoconazole interaction evaluation

Group Type OTHER

ketoconazole

Intervention Type DRUG

Ketoconazole oral tablets, 200 mg bid, 14 days

Interventions

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SAM-760

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

Intervention Type DRUG

Placebo of SAM-760

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

Intervention Type DRUG

ketoconazole

Ketoconazole oral tablets, 200 mg bid, 14 days

Intervention Type DRUG

Other Intervention Names

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Placebo ketoconazole interaction arm

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes