A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
CES1
1 other identifier
interventional
20
1 country
1
Brief Summary
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 healthy
Started Jul 2013
Typical duration for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 15, 2013
CompletedFirst Posted
Study publicly available on registry
July 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedMay 19, 2014
May 1, 2014
5 months
July 15, 2013
May 15, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
Oseltamivir pharmacokinetic parameters
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Up to 0 to 48 h post dose
Oseltamivir carboxylate pharmacokinetic parameters
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Up to 0 to 48 h post dose
Secondary Outcomes (2)
Other oseltamivir pharmacokinetic parameters
Up to 0 to 48 h post dose
Other oseltamivir carboxylate pharmacokinetic parameters
Up to 0 to 48 h post dose
Study Arms (2)
CES1 gene variant group
EXPERIMENTALOseltamivir 75 mg 1 cap
CES1 gene wild type group
EXPERIMENTALOseltamivir 75 mg 1 cap
Interventions
Eligibility Criteria
You may qualify if:
- Healthy subjects:
- Agreement with written informed consent
- Adult healthy male or female subject age 20 to 45
You may not qualify if:
- Clinically significant, active gastrointestinal system, cardiovascular system, pulmonary system, renal system, endocrine system, blood system, digestive system, central nervous system, mental disease or malignancy
- Medication with any drug which may affect the pharmacokinetics of oseltamivir within 14 days
- Previously donate whole blood within 30 days or Previously participated in other trial within 60 days
- Subject with known for hypersensitivity reactions to oseltamivir
- Subject who perform contraception during study periods
- Female woman who are pregnant or are breast feeding
- An impossible one who participates in clinical trial by investigator's decision including laboratory test result
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Hospital Clinical Trial Center
Seoul, 110-768, South Korea
Related Publications (1)
Oh J, Lee S, Lee H, Cho JY, Yoon SH, Jang IJ, Yu KS, Lim KS. The novel carboxylesterase 1 variant c.662A>G may decrease the bioactivation of oseltamivir in humans. PLoS One. 2017 Apr 24;12(4):e0176320. doi: 10.1371/journal.pone.0176320. eCollection 2017.
PMID: 28437488DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kyoung Soo Lim, MD, PhD
Seoul National University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 15, 2013
First Posted
July 18, 2013
Study Start
July 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
May 19, 2014
Record last verified: 2014-05