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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00966966
• Other study ID #: 3193A1-1109
• Secondary ID: B1961001
• Status: Completed
• Phase: Phase 1
• First received: August 26, 2009
• Last updated: August 18, 2010
• Start date: September 2009
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• SAM-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

Locations

Country	Name	City	State
Netherlands	Pfizer Investigational Site	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer	Pfizer

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum plasma concentration (Cmax)		24 days	No
Primary	Time to maximum plasma concentration (tmax)		24 days	No
Primary	Area under the concentration-time curve (AUC)		24 days	No
Secondary	Safety as measured by adverse event monitoring, ECG, vital signs, and laboratory tests		24 days	Yes

External Links

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