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

• Sponsor: Bausch Health Americas, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00743912
• Collaborator: (none)
• Enrollment: 24
• Arm: 1
• Duration (Months): 2

Study Details

Study Description

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 Design

• Study Type: Interventional
• Actual Enrollment: 24 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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: Sep 1, 2008
• Actual Primary Completion Date: Oct 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized. [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. [21 tyo 38 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Bausch Health Americas, Inc.

Investigators

• Principal Investigator: William Lewis, MD, Covance CRU, Inc

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch Health Americas, Inc.
• ClinicalTrials.gov Identifier: NCT00743912
• Other Study ID Numbers: RFDI1008
• First Posted: Aug 29, 2008
• Last Update Posted: Nov 29, 2019
• Last Verified: Nov 1, 2019

• Keywords provided by Bausch Health Americas, Inc.: rifaximin; midazolam; pharmacokinetics
• Additional relevant MeSH terms: Rifaximin

Study Results

No Results Posted as of Nov 29, 2019