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

Pharmacokinetic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743912
• Other study ID #: RFDI1008
• Status: Completed
• Phase: Phase 1
• Start date: September 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: November 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pharmacokinetic

Intervention

Drug:
• rifaximin
550 mg TID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.		21 to 38 days (including a 21 day screening period)
Secondary	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