Open-Label Study to Evaluate the Effect of Rifaximin on Midazolam in Normal Healthy Volunteers - Full Text View

Sponsored by:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00743912

Purpose

The primary objective of this study is to determine if rifaximin, administered daily has an effect on the cytochrome P450 (CYP) isoenzyme 3A4, by examining any changes in the pharmacokinetics of midazolam (a CYP3A4 substrate), when co-administered.

Condition	Intervention	Phase
Pharmacokinetic	Drug: rifaximin	Phase I

Drug Information available for: Midazolam Midazolam hydrochloride Midazolam maleate Rifaximin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study
Official Title:	A Phase 1, Single Arm, Open-Label Study to Evaluate the Effect of Rifaximin 550 MG Tablets TID on the Pharmacokinetics of Orally Administered Midazolam in Healthy Male and Female Volunteers

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. [ Time Frame: 21 to 38 days (including a 21 day screening period) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Overall safety assessments will include the incidence, intensity, and type of adverse events, and clinically significant changes in the patient's physical examination, vital signs and laboratory results. [ Time Frame: 21 tyo 38 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	24
Study Start Date:	September 2008
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental open-label rifaximin 550 mg TID	Drug: rifaximin 550 mg TID

Detailed Description:

This is a single-site, single-arm, open-label, drug-interaction study that examines the effect of rifaximin (RFX), 550 mg 3 times daily (TID; 1650 mg/day), on orally administered (PO) midazolam (MDZ) 2 mg (administered as a 2 mg dose in 1 mL of midazolam HCL Syrup; 2 mg/mL) when dosed for 7 and 14 consecutive days, respectively.

Eligibility

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

Criteria

Inclusion Criteria:

Patient is medically normal
Patient has normal laboratory values
Patient has the ability to understand the requirements of the study

Exclusion Criteria:

HIV
Hepatitis B
Hepatitis C
History of renal, hepatic, endocrine, oncological, gastrointestinal or cardiovascular disease.
History of epilepsy, asthma, diabetes, psychosis, glaucoma or severe head injury.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00743912

Locations

United States, Texas
Covance CRU	Recruiting
Dallas, Texas, United States, 75247
Contact: Tyson Dudley tyson.dudley@covance.com

Sponsors and Collaborators

Salix Pharmaceuticals

Investigators

Principal Investigator:

William Lewis, MD

Covance CRU, Inc

More Information

Responsible Party:	Salix Pharmaceuticals, Inc. ( Audrey Shaw, Director Clinical Development )
Study ID Numbers:	RFDI1008
Study First Received:	August 27, 2008
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00743912
Health Authority:	United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:

rifaximin
midazolam
pharmacokinetics

Study placed in the following topic categories:

Rifaximin
Healthy
Midazolam

Additional relevant MeSH terms:

Anesthetics, Intravenous
Anti-Infective Agents
Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Gastrointestinal Agents
Psychotropic Drugs
Central Nervous System Depressants

Anesthetics
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Therapeutic Uses
Hypnotics and Sedatives
GABA Agents
Anti-Anxiety Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 16, 2009