NCT02097953

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at P25-P50 for early_phase_1

Timeline
Completed

Started May 2014

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

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

March 24, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 27, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

December 12, 2016

Status Verified

December 1, 2016

Enrollment Period

1.1 years

First QC Date

March 24, 2014

Last Update Submit

December 9, 2016

Conditions

Drug InteractionsPharmacokinetics

Keywords

DaptomycinRifampinP-glycoproteinPharmacokinetic

Outcome Measures

Primary Outcomes (8)

  • Daptomycin total, renal, and non-renal clearance

    Total, renal, and non-renal clearance of daptomycin before and after administration of rifampin

    14 days

  • Daptomycin Volume of Distribution

    The volume of distribution of daptomycin before and after administration of rifampin

    14 days

  • Daptomycin Elimination Rate Constant

    The elimination rate constant of daptomycin before and after administration of rifampin

    14 days

  • Daptomycin Free and Total Peak Concentrations

    The free and total peak concentrations of daptomycin before and after administration of rifampin

    14 days

  • Daptomycin Free and Total 24 hour Concentrations

    The free and total 24 hour concentrations of daptomycin before and after administration of rifampin

    14 days

  • Daptomycin Free and Total Area Under the Concentration-Time Curve (AUC) from 0 to 24 hours

    The free and total AUC from 0 to 24 hours of daptomycin before and after administration of rifampin

    14 days

  • Daptomycin Free and Total AUC from 0 to Infinity

    The free and total AUC from 0 to infinity of daptomycin before and after administration of rifampin

    14 days

  • Percent Protein Binding of Daptomycin

    The percent protein binding of daptomycin before and after administration of rifampin

    14 days

Secondary Outcomes (2)

  • P-glycoprotein Polymorphism

    14 days

  • Number of Participants with Adverse Events

    45 days

Study Arms (1)

Daptomycin and Rifampin

EXPERIMENTAL

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

Drug: DaptomycinDrug: Rifampin

Interventions

DaptomycinDRUG
Also known as: Cubicin
Daptomycin and Rifampin
RifampinDRUG
Also known as: Rifadin
Daptomycin and Rifampin

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Interventions

DaptomycinRifampin

Intervention Hierarchy (Ancestors)

Peptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsLipopeptidesLipidsPeptidesAmino Acids, Peptides, and ProteinsRifamycinsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsLactams, Macrocyclic

Study Officials

  • Russell Benefield, Pharm.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmacist

Study Record Dates

First Submitted

March 24, 2014

First Posted

March 27, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2015

Study Completion

July 1, 2016

Last Updated

December 12, 2016

Record last verified: 2016-12

Locations

US(1)