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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00966966
• Date of registration: 26/08/2009
• Prospective Registration: Yes
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study Evaluating Potential Interaction Between SAM-531 And Gemfibrozil When Co-Administered
• Scientific title: 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
• Date of first enrolment: September 2009
• Target sample size: 17
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00966966
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Netherlands

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: SAM-531 and gemfibrozil

Primary Outcome(s)

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 Outcome(s)

Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests [Time Frame: 24 days]

Secondary ID(s)

B1961001

3193A1-1109

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Pfizer