Study Evaluating The Potential Interaction Between Verapamil Immediate Release And SAM-531 When Co-Administered

An Open-label, Nonrandomized Study to Evaluate the Potential Pharmacokinetic Interaction Between Multiple Doses of Verapamil Immediate Release (IR) and a Single Dose of SAM-531 When Co-administered Orally to Healthy Young Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745576

Enrollment

Registered

2008-09-03

Start date

2008-10-31

Completion date

2008-12-31

Last updated

2010-02-08

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

Conditions

Alzheimer Disease

Brief summary

The purpose of this study is to evaluate the effects of multiple doses of verapamil on the plasma concentration of a single dose of SAM-531 in healthy young adult subjects and to assess the safety and tolerability of co-administration of SAM-531 and verapamil.

Interventions

DRUGSAM-531

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion criteria

: 1. Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. 2. Healthy as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12-lead ECG readings.

Exclusion criteria

: 1. Presence or history of any disorder that may prevent the successful completion of the study. 2. Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal (GI), endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.

Design outcomes

Primary

Measure	Time frame
blood samples	7 weeks

Secondary

Measure	Time frame
Safety based on supine vital signs evaluations, 12-lead ECGs and routine lab tests	7 weeks

Countries

France

Outcome results

None listed

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