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

Bausch Health

Status and phase: Completed; Phase 1

Conditions: Pharmacokinetic

Treatments: Drug: rifaximin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00743912

RFDI1008

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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24 participants in 1 patient group

1

Experimental group

Description:

open-label rifaximin 550 mg TID

Treatment:

Drug: rifaximin