Aripiprazole and Effexor XR Drug Interaction Study

Otsuka Pharmaceutical Development & Commercialization, Inc.38 enrolled

Overview

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

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

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.DRUG

Tablets, Oral, Venlafaxine: 75 mg; Aripiprazole: 10, 15, 20 mg once daily, 14 days.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Miami, Florida, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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