Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered

An Open-Label, Nonrandomized Study To Evaluate The Potential Pharmacokinetic Interaction Between SAM-531 and Gemfibrozil, A Cytochrome P-450 2C8 Inhibitor, When Coadministered Orally To Healthy Young Adult Subjects

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00966966

Enrollment

Registered

2009-08-27

Start date

2009-09-30

Completion date

2009-12-31

Last updated

2010-08-20

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

Conditions

Healthy

Keywords

Alzheimer Disease

Brief summary

The purpose of this study is to evaluate the effects of multiple doses of Gemfibrozil 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 Gemfibrozil.

Interventions

DRUGSAM-531 and gemfibrozil

2 single doses of 5 mg SAM-531 (capsules) a daily dose of 1200 mg Gemfibrozil (one tablet of 600mg at approximately 8 a.m. and one tablet of 600 mg at approximately 6 p.m.) for 14 days

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

* Body mass index in the range of 18 to 30 kg/m2 and body weight greater than 50 kg. * 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

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

Design outcomes

Primary

Measure	Time frame
Maximum plasma concentration (Cmax)	24 days
Time to maximum plasma concentration (tmax)	24 days
Area under the concentration-time curve (AUC)	24 days

Secondary

Measure	Time frame
Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests	24 days

Countries

Netherlands

Outcome results

None listed

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