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Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin

NCT ID: NCT02097953

Last Updated: 2016-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2016-07-31

Brief Summary

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The purpose of this study is to understand how an antibiotic, rifampin, may change the blood levels of another antibiotic, daptomycin, in the body. In addition, the effect of polymorphisms in P-glycoprotein (a protein involved in the removal of daptomycin from the body) on the blood levels of daptomycin will be evaluated. The hypotheses are that rifampin will decrease the blood levels of daptomycin and that the effect will be greater for certain P-glycoprotein polymorphisms.

Detailed Description

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This will be an open-label, sequential pharmacokinetic study in 12 healthy volunteers. After providing informed consent, participants meeting inclusion criteria will be administered daptomycin 6 mg/kg over 2 minutes and blood and urine samples will be collected over a 24 hour period after infusion. Following this, participants will be given a 13 day supply of rifampin 600 mg/day to be taken at home. After completion of the rifampin course, a second pharmacokinetic sampling will be performed (day 15 overall). Participants will be administered a dose of rifampin 600 mg then once again be administered daptomycin 6 mg/kg over 2 minutes and blood and urine samples will be collected over a second 24 hour period. A blood sample will be obtained at the first study visit for determination of each participant's P-glycoprotein genotype.

Conditions

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Drug Interactions Pharmacokinetics

Keywords

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Daptomycin Rifampin P-glycoprotein Pharmacokinetic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daptomycin and Rifampin

Drug: Daptomycin Daptomycin 6 mg/kg will be given by IV infusion on the first study day Drug: Rifampin Rifampin 600 mg capsules will be given orally once daily for 14 days starting on study day 2 Drug: Daptomycin Daptomycin 6 mg/kg will be given by IV infusion on study day 15

Group Type EXPERIMENTAL

Daptomycin

Intervention Type DRUG

Rifampin

Intervention Type DRUG

Interventions

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Daptomycin

Intervention Type DRUG

Rifampin

Intervention Type DRUG

Other Intervention Names

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Cubicin Rifadin

Eligibility Criteria

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Inclusion Criteria

* Ability to provide informed consent
* If female of child bearing potential, on reliable method of contraception and negative pregnancy test at enrollment

Exclusion Criteria

* Obesity (body mass index \> 30)
* Creatinine clearance \< 80 ml/min
* Creatine phosphokinase \> 2 times upper limit of normal at enrollment
* Aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatase \> 3 times upper limit of normal at enrollment
* History of liver disease or cirrhosis
* History of congestive heart failure
* Allergy or intolerance to rifampin or daptomycin
* Need for concomitant non-study medications during the study period
* Inability to abstain from grapefruit juice or herbal supplements (such as St. John's wort) during the study period
* Receipt of study drugs within 30 days prior to enrollment
* Pregnancy or lactation
* Inability to adhere to study procedures
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

INDUSTRY

Sponsor Role collaborator

University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Russell Benefield

Pharmacist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Russell Benefield, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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University of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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00069136

Identifier Type: -

Identifier Source: org_study_id