Official Title: “Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects”

The purpose of this clinical research study is to learn whether aripiprazole has effect on the steady-state pharmacokinetics of venlafaxine in healthy subjects. The safety and tolerability of aripiprazole and venlafaxine co-administration will also be studied.

Study Type: Interventional

Study Design: Other, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacokinetics Study

Intervention(s) in this Clinical Trial

• Drug: Venlafaxine on Day -4 to day 14, Aripiprazole dosed starting on Day 1: 3 days at 10 mg, 4 days at 1 mg and 7 days at 20 mg.
  • Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.

Arms, Groups and Cohorts in this Clinical Trial

• Other: 1

Primary Measures

• Multiple dose PK parameters for venlafaxine+metabolite when administered alone and with aripiprazole will be derived. Cmin for aripiprazole,dehydro-aripiprazole will be measured

Secondary Measures

• Safety will be based on review of AEs, VS, ECGs, physical exam, clinical labs

Inclusion Criteria:

• Healthy male and female subjects, ages 18 to 45 (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the study in such a manner that the risk of pregnancy is minimized.
• Body Mass Index (BMI) of 18 to 33 kg/m2, inclusive.

Exclusion Criteria:

• Subjects with a decrease in SBP of >=20 mm Hg and increase in HR of >=20 bpm after 2 minutes standing vs. 2 minutes supine at screening or with frank orthostatic hypotension at screening.
• Supine BP of 90/50 mm Hg or lower at screening
• SBP >=140 mm Hg or DBP >=90 mm Hg at screening

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: Bristol-Myers Squibb

Overall Clinical Trial Officials and Contacts

Bristol-Myers Squibb Study Director Bristol-Myers Squibb  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00362271

Study ID Number: CN138-462 ST

ClinicalTrials.gov Identifier: NCT00362271

Health Authority: United States: Food and Drug Administration

BMS Clinical Trials Disclosure

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