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Clinical Trials/NCT00966966
NCT00966966CompletedPhase 1

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

Wyeth is now a wholly owned subsidiary of Pfizer1 site in 1 country17 target enrollmentStarted: September 2009Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Sponsor
Enrollment
17
Locations
1
Primary Endpoint
Maximum plasma concentration (Cmax)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 55 Years (Adult)
Sex
All
Accepts 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.

Arms & Interventions

1

Experimental

SAM-531_gemfibrozil

Intervention: SAM-531 and gemfibrozil (Drug)

Outcomes

Primary Outcomes

Maximum plasma concentration (Cmax)

Time Frame: 24 days

Time to maximum plasma concentration (tmax)

Time Frame: 24 days

Area under the concentration-time curve (AUC)

Time Frame: 24 days

Secondary Outcomes

  • Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests(24 days)

Investigators

Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor Class
Industry

Study Sites (1)

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