Simvastatin Pharmacokinetics and Gut MicrobiomePhase 1NCT03403972
Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
A Phase 1 study testing Vancomycin 250Mg Capsule in people with Simvastatin Pharmacokinetics and Gut Microbiome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Simvastatin Pharmacokinetics and Gut Microbiome
- What is being tested?
- Vancomycin 250Mg Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSouth Korea
- Study dates
- 6 Dec 2017to 11 Jan 2018
- Phase
- 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 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 19 Y to 50 Y at the screening
- Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg/m2
- Informed consent will be taken before all the procedures from volunteers
- SLCO1B1 genotype is *1/*1 when screening
Who cannot join
- No significant disease history or ongoing disease
- Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin
- MDRD eGFR less than 60 mL/min/1.73m2
- Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening
- HDL less than 35 mg/dL at the screening
- Positive HBV or HIV or HCV
- Who is administering or going to administer CYP3A4 inihibitor drug
- Other clinically significant situation under doctor's opinion
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 03080
About this study
Official title: A Clinical Trial to Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.
- Being tested
- Vancomycin 250Mg Capsule
- Keywords
- pharmacokinetics, simvastatin, vancomycin, gut microbiome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vancomycin 250Mg CapsuleDrug
Also called simvastatin
Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.
| Study group | Role | What they receive |
|---|---|---|
| Group | Experimental | Intervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule) Receives: Drug: Vancomycin 250Mg Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the maximum plasma concentration (Cmax)
Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment.
Measured: vancomycin PO will administered for 7 days
Compare the area under the time-plasma concentration curve (AUC)
Compare the area under the time-plasma concentration curve (AUC) of simvastatin before and after vancomycin PO treatment.
Measured: vancomycin PO will administered for 7 days
Secondary outcomes (1)
Explore the gut microbiome species change
Explore how the gut microbiome species change after vancomycin multiple dosing for 7 days
Measured: vancomycin PO will administered for 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start6 Dec 2017
- Primary completion11 Jan 2018
- Study completion11 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Simvastatin Pharmacokinetics and Gut MicrobiomeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SeungHwan Lee, Seoul National University Hospital
- Investigators
- SeungHwan Lee, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403972
- Sponsor's protocol ID
- MBSVT_PK
- Status last verified
- Jan 2018
- First submitted
- 15 Oct 2017
- Last updated
- 19 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators have no plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT03403972
- Acronym / sponsor ID
- MBSVT_PK
- Keywords
- pharmacokinetics, simvastatin, vancomycin, gut microbiome
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 11 Jan 2018 (actual)
- Study completion
- 11 Jan 2018 (actual)
- First posted
- 19 Jan 2018 (actual)
- 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.
This phase 1 clinical trial is to evaluate the effects of the environmental change in intestine by antibiotics on the pharmacokinetic characteristics of simvastatin in healthy male volunteers. For change of intestine environment, especially the gut microbiota, investigators will administer PO vancomycin for 7 days, tid.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group | Experimental | Drug: Vancomycin 250Mg CapsuleIntervention: vancomycin 500 mg tid for 7 days (Vancozin 250 mg capsule) |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 19 Y to 50 Y at the screening
- Body weight over 55 kg and BMI should be between 18.0 to 25.0 kg/m2
- Informed consent will be taken before all the procedures from volunteers
- SLCO1B1 genotype is *1/*1 when screening
Key exclusion criteria (8 listed)
- No significant disease history or ongoing disease
- Allergic to simvastatin and vancomycin, or similar affiliation drug for simvastatin or vancomycin
- MDRD eGFR less than 60 mL/min/1.73m2
- Total cholesterol, LDL, TG is higher than 1.5 times more than upper normal limit at the screening
- HDL less than 35 mg/dL at the screening
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 |
|---|---|---|
| Vancomycin 250Mg CapsuleAlso: simvastatinInvestigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration. | Drug | Group |
Primary outcome
Compare the maximum plasma concentration (Cmax)
Time frame: vancomycin PO will administered for 7 days
Compare the maximum plasma concentration (Cmax) of simvastatin before and after vancomycin PO treatment.
Compare the area under the time-plasma concentration curve (AUC)
Time frame: vancomycin PO will administered for 7 days
Compare the area under the time-plasma concentration curve (AUC) of simvastatin before and after vancomycin PO treatment.
1 secondary outcome
Explore the gut microbiome species change
Time frame: vancomycin PO will administered for 7 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 19 Jan 2018.
- Individual participant dataSharing planned: No. Investigators have no plan to share individual participant data.
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.
SeungHwan Lee, MD, PhD principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Vancomycin 250Mg Capsule in people with Simvastatin Pharmacokinetics and Gut Microbiome, run by Seoul National University Hospital at 1 site in South Korea.
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 4 inclusion and 8 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 19 Jan 2018. 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 South Korea. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Compare the maximum plasma concentration (Cmax) (time frame: vancomycin PO will administered for 7 days). The study lists 2 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 19 Jan 2018.