Aripiprazole and Effexor XR Drug Interaction Study

This study has been completed.
Sponsor:
Information provided by:
Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier:
NCT00362271
First received: August 7, 2006
Last updated: November 7, 2013
Last verified: June 2008
  Purpose

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.


Condition Intervention Phase
Healthy
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.
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effects of Aripiprazole on the Steady-State Pharmacokinetics of Venlafaxine in Healthy Subjects

Resource links provided by NLM:


Further study details as provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:

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

Estimated Enrollment: 38
Study Start Date: August 2006
Study Completion Date: September 2006
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 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.
Other Name: Abilify

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00362271

Locations
United States, Florida
Local Institution
Miami, Florida, United States
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Otsuka Pharmaceutical Development & Commercialization, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00362271     History of Changes
Other Study ID Numbers: CN138-462 ST
Study First Received: August 7, 2006
Last Updated: November 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Otsuka Pharmaceutical Development & Commercialization, Inc.:
Healthy Subjects

Additional relevant MeSH terms:
Aripiprazole
Venlafaxine
Antidepressive Agents
Antidepressive Agents, Second-Generation
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014