Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315

Phase 1TerminatedNCT00474552

Wyeth is now a wholly owned subsidiary of Pfizer56 enrolled

Overview

Primary: To assess the safety and tolerability of ascending multiple oral doses of SAM-315, an investigational drug, in healthy young adult and elderly subjects. Secondary: To assess the Pharmacokinetic and Pharmacodynamic profiles of multiple oral doses of SAM-315 in healthy young adult and elderly subjects.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer Disease

Interventions

SAM-315DRUG

Multiple Ascending Doses of SAM-315 (treatment duration: 14 days): 0.2 mg; 0.5 mg; 1 mg; 2 mg;

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Young healthy subjects: * Men and women of nonchildbearing potential (WONCBP) aged 18 to 45 years inclusive on study day 1. * Body mass index (BMI) in the range of 18 to 30 kg/m2 and body weight greater than or equal to 50 kg and body weight greater than or equal to 50 kg. Elderly Healthy subjects: * Men or women aged 65 years and above as of study day 1. * BMI in the range of 18 to 30 kg/m2 and body weight greater than or equal to 45 kg and body weight greater than or equal to 45 kg. Exclusion Criteria: * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease. * History of any clinically important drug allergy.

Locations (1)

Unnamed facility

Paris, France

Outcomes

Primary Outcomes

safety, tolerability and PK

Time frame: 10 months

Data from ClinicalTrials.gov

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