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

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Utah
• Collaborator: Cubist Pharmaceuticals LLC
• Treatments: Daptomycin; Rifampin

Criteria

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