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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00743912
Recruitment Status : Completed
First Posted : August 29, 2008
Last Update Posted : December 22, 2009
Information provided by:
Valeant Pharmaceuticals International, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Pharmacokinetic Drug: rifaximin Phase 1

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
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
Study Start Date : September 2008
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
open-label rifaximin 550 mg TID
Drug: rifaximin
550 mg TID

Primary Outcome Measures :
  1. Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. [ Time Frame: 21 to 38 days (including a 21 day screening period) ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00743912

Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Principal Investigator: William Lewis, MD Covance CRU, Inc

Responsible Party: Audrey Shaw, Director Clinical Development, Salix Pharmaceuticals, Inc. Identifier: NCT00743912     History of Changes
Other Study ID Numbers: RFDI1008
First Posted: August 29, 2008    Key Record Dates
Last Update Posted: December 22, 2009
Last Verified: December 2009

Keywords provided by Valeant Pharmaceuticals International, Inc.:

Additional relevant MeSH terms:
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Anti-Bacterial Agents