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

An Ascending Multiple-Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAM-315 Administered Orally to Healthy Young Adult and Elderly Subjects

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00474552

Enrollment

Registered

2007-05-17

Start date

2007-06-30

Completion date

2007-10-31

Last updated

2008-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

Brief summary

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.

Interventions

DRUGSAM-315

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

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame
safety, tolerability and PK	10 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026