Drug Interactions | Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
Drug Interactions research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Daptomycin and RifampinDrug: 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
Start Date: May 2014
Completed Date: July 2016
Phase: Early Phase 1
Primary Outcome: Daptomycin total, renal, and non-renal clearance
Secondary Outcome: P-glycoprotein Polymorphism
Study sponsors, principal investigator, and references
Principal Investigator: Russell Benefield, Pharm.D.
Lead Sponsor: University of Utah
Collaborator: Cubist Pharmaceuticals LLC