NCT00743912

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 27, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 29, 2008

Completed
3 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

November 29, 2019

Status Verified

November 1, 2019

Enrollment Period

1 month

First QC Date

August 27, 2008

Last Update Submit

November 26, 2019

Conditions

Pharmacokinetic

Keywords

rifaximinmidazolampharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • Individual midazolam and rifaximin plasma concentrations and pharmacokinetic parameters will be summarized.

    21 to 38 days (including a 21 day screening period)

Secondary Outcomes (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

Study Arms (1)

1

EXPERIMENTAL

open-label rifaximin 550 mg TID

Drug: rifaximin

Interventions

rifaximinDRUG

550 mg TID

1

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patient is medically normal
  • Patient has normal laboratory values
  • Patient has the ability to understand the requirements of the study

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Rifaximin

Intervention Hierarchy (Ancestors)

RifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, MacrocyclicMacrocyclic CompoundsPolycyclic Compounds

Study Officials

  • William Lewis, MD

    Covance CRU, Inc

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2008

First Posted

August 29, 2008

Study Start

September 1, 2008

Primary Completion

October 1, 2008

Study Completion

November 1, 2008

Last Updated

November 29, 2019

Record last verified: 2019-11