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

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.

Completed

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Key information

Conditions

Pharmacokinetic

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Rifaximin

Drug

550 mg TID

Primary outcomes

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 outcomes

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

Sponsors and collaborators

Lead sponsor

Bausch Health Americas, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2008
Primary completion: 2008
Study completion: 2008
First posted: Aug 29, 2008
Registry last updated: Nov 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed