Aripiprazole and Lexapro Drug Interaction Study - Full Text View

Purpose

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

Condition	Intervention	Phase
Healthy	Drug: Escitalopram on days -7 to day 14; Aripiprazole dosed starting Day 1 to day 14: 3 days at 10 mg, 4 days at 15 mg and 7 days at 20 mg	Phase I

ChemIDplus related topics:

Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate Aripiprazole

U.S. FDA Resources

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

Official Title:	Effects on Aripiprazole on the Steady-State Pharmacokinetics of Escitalopram in Healthy Subjects

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Multiple dose PK parameters for Lexapro when administered alone and coadministered 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:	25
Study Start Date:	August 2006

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

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 in 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00361790

Locations


United States, Kansas
	Local Institution
	Lenexa, Kansas, United States

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators


Study Director:	Bristol-Myers Squibb	Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Study ID Numbers:	CN138-463 ST
First Received:	August 7, 2006
Last Updated:	June 27, 2008
ClinicalTrials.gov Identifier:	NCT00361790
Health Authority:	United States: Food and Drug Administration

Keywords provided by Bristol-Myers Squibb:

Healthy Subjects

Study placed in the following topic categories:

Aripiprazole

Healthy

Dexetimide

Citalopram

Serotonin

Additional relevant MeSH terms:

Parasympatholytics

Neurotransmitter Uptake Inhibitors

Neurotransmitter Agents

Tranquilizing Agents

Molecular Mechanisms of Pharmacological Action

Cholinergic Antagonists

Anti-Dyskinesia Agents

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antiparkinson Agents

Antipsychotic Agents

Cholinergic Agents

Serotonin Uptake Inhibitors

Pharmacologic Actions

Muscarinic Antagonists

Serotonin Agents

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Antidepressive Agents, Second-Generation

Central Nervous System Agents

Antidepressive Agents

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00361790