Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
Completed · Early Phase 1
Conditions studied: Drug Interactions, Pharmacokinetics
In brief
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.
Key facts
- Study ID
- NCT02097953
- Run by
- University of Utah
- People needed
- 12
- Starts
- 2014-05-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2016-12-12
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
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
Where it is running
- University of Utah — Salt Lake City, Utah, United States
Full record on ClinicalTrials.gov
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