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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00743912
First received: August 27, 2008
Last updated: December 21, 2009
Last verified: December 2009
  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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


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 ]

Enrollment: 24
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
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: NCT00743912

Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Principal Investigator: William Lewis, MD Covance CRU, Inc
  More Information

No publications provided

Responsible Party: Audrey Shaw, Director Clinical Development, Salix Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT00743912     History of Changes
Other Study ID Numbers: RFDI1008
Study First Received: August 27, 2008
Last Updated: December 21, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
rifaximin
midazolam
pharmacokinetics

Additional relevant MeSH terms:
Midazolam
Rifaximin
Adjuvants, Anesthesia
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Anti-Anxiety Agents
Anti-Infective Agents
Central Nervous System Agents
Central Nervous System Depressants
GABA Agents
GABA Modulators
Gastrointestinal Agents
Hypnotics and Sedatives
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 25, 2014