Drug InteractionsEarly Phase 1NCT02097953
Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
A Early Phase 1 study testing Daptomycin and Rifampin in people with Drug Interactions and Pharmacokinetics, run by University of Utah at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Drug Interactions, Pharmacokinetics
- What is being tested?
- Daptomycin and Rifampin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Jul 2016
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability to provide informed consent
- If female of child bearing potential, on reliable method of contraception and negative pregnancy test at enrollment
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About 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.
Read the detailed description
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
- Drug Interactions, Pharmacokinetics
- Being tested
- Daptomycin, Rifampin
- Keywords
- Daptomycin, Rifampin, P-glycoprotein, Pharmacokinetic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaptomycinDrug
Also called Cubicin
RifampinDrug
Also called Rifadin
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Daptomycin; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daptomycin total, renal, and non-renal clearance
Total, renal, and non-renal clearance of daptomycin before and after administration of rifampin
Measured: 14 days
Daptomycin Volume of Distribution
The volume of distribution of daptomycin before and after administration of rifampin
Measured: 14 days
Daptomycin Elimination Rate Constant
The elimination rate constant of daptomycin before and after administration of rifampin
Measured: 14 days
Daptomycin Free and Total Peak Concentrations
The free and total peak concentrations of daptomycin before and after administration of rifampin
Measured: 14 days
Daptomycin Free and Total 24 hour Concentrations
The free and total 24 hour concentrations of daptomycin before and after administration of rifampin
Measured: 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
Measured: 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
Measured: 14 days
Percent Protein Binding of Daptomycin
The percent protein binding of daptomycin before and after administration of rifampin
Measured: 14 days
Secondary outcomes (2)
P-glycoprotein Polymorphism
The effect of different P-glycoprotein polymorphisms on the pharmacokinetic profile of daptomycin before and after administration of rifampin will be assessed
Measured: 14 days
Number of Participants with Adverse Events
Safety monitoring will be done by regular adverse event assessment, laboratory and vital sign monitoring, and physical exam.
Measured: 45 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Responsible party
- Principal investigator, Russell Benefield, University of Utah
- Investigators
- Russell Benefield, Pharm.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097953
- Sponsor's protocol ID
- 00069136
- Status last verified
- Dec 2016
- First submitted
- 24 Mar 2014
- Last updated
- 12 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Rifampin Co-Administration on the Pharmacokinetic Profile of Daptomycin
- ClinicalTrials.gov ID
- NCT02097953
- Acronym / sponsor ID
- 00069136
- Conditions
- Drug Interactions, Pharmacokinetics
- Keywords
- Daptomycin, Rifampin, P-glycoprotein, Pharmacokinetic
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
- Study start
- May 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Daptomycin and Rifampin | Experimental | Drug: Daptomycin, Drug: 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Ability to provide informed consent
- If female of child bearing potential, on reliable method of contraception and negative pregnancy test at enrollment
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DaptomycinAlso: Cubicin | Drug | Daptomycin and Rifampin |
| RifampinAlso: Rifadin | Drug | Daptomycin and Rifampin |
Primary outcome
Daptomycin total, renal, and non-renal clearance
Time frame: 14 days
Total, renal, and non-renal clearance of daptomycin before and after administration of rifampin
Daptomycin Volume of Distribution
Time frame: 14 days
The volume of distribution of daptomycin before and after administration of rifampin
Daptomycin Elimination Rate Constant
Time frame: 14 days
The elimination rate constant of daptomycin before and after administration of rifampin
Daptomycin Free and Total Peak Concentrations
Time frame: 14 days
The free and total peak concentrations of daptomycin before and after administration of rifampin
Daptomycin Free and Total 24 hour Concentrations
Time frame: 14 days
The free and total 24 hour concentrations of daptomycin before and after administration of rifampin
Daptomycin Free and Total Area Under the Concentration-Time Curve (AUC) from 0 to 24 hours
Time frame: 14 days
The free and total AUC from 0 to 24 hours of daptomycin before and after administration of rifampin
Daptomycin Free and Total AUC from 0 to Infinity
Time frame: 14 days
The free and total AUC from 0 to infinity of daptomycin before and after administration of rifampin
Percent Protein Binding of Daptomycin
Time frame: 14 days
The percent protein binding of daptomycin before and after administration of rifampin
2 secondary outcomes
P-glycoprotein Polymorphism
Time frame: 14 days
Number of Participants with Adverse Events
Time frame: 45 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Russell Benefield, Pharm.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Daptomycin and Rifampin in people with Drug Interactions and Pharmacokinetics, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daptomycin total, renal, and non-renal clearance (time frame: 14 days). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016; AzTrials last refreshed its copy on 8 Nov 2026.