Status:
COMPLETED
Evaluate the Effects of the Environmental Change in Intestine by Antibiotics on the Pharmacokinetic Characteristics of Simvastatin in Healthy Male Volunteers
Lead Sponsor:
Seoul National University Hospital
Conditions:
Simvastatin Pharmacokinetics and Gut Microbiome
Eligibility:
MALE
19-50 years
Phase:
PHASE1
Brief 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. For cha...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2018
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT03403972
Start Date
December 6 2017
End Date
January 11 2018
Last Update
January 19 2018
Active Locations (1)
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1
Seoul National University Hospital Clinical Trial Center
Seoul, South Korea, 03080