HealthyPhase 1CES1NCT01902342
A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Oseltamivir
A Phase 1 study testing Oseltamivir 75 mg 1 cap in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers. Read more about this study
- Who is it for?
- Ages 20 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Oseltamivir 75 mg 1 cap
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2013to Dec 2013
- 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 20 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects:
- Agreement with written informed consent
- Adult healthy male or female subject age 20 to 45
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 110-768
About this study
Official title: A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.
- Conditions
- Healthy
- Being tested
- Oseltamivir 75 mg 1 cap
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oseltamivir 75 mg 1 capDrug
Also called Tamiflu
| Study group | Role | What they receive |
|---|---|---|
| CES1 gene variant group | Experimental | Oseltamivir 75 mg 1 cap Receives: Drug: Oseltamivir 75 mg 1 cap |
| CES1 gene wild type group | Experimental | Oseltamivir 75 mg 1 cap Receives: Drug: Oseltamivir 75 mg 1 cap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oseltamivir pharmacokinetic parameters
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Measured: 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)
Measured: Up to 0 to 48 h post dose
Secondary outcomes (2)
Other oseltamivir pharmacokinetic parameters
first time to reach Cmax (tmax), terminal half-life (t1/2z), apparent clearance (CL/F), apparent renal clearance (CLR/F), metabolic ratio
Measured: Up to 0 to 48 h post dose
Other oseltamivir carboxylate pharmacokinetic parameters
first time to reach Cmax (tmax), terminal half-life (t1/2z), apparent clearance (CL/F), apparent renal clearance (CLR/F), metabolic ratio
Measured: Up to 0 to 48 h post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startJul 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyoung Soo Lim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902342
- Sponsor's protocol ID
- CES01
- Acronym
- CES1
- Status last verified
- May 2014
- First submitted
- 15 Jul 2013
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28437488
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Investigate the Influence of CES1 Polymorphism on Pharmacokinetic Characteristics of Oseltamivir in Healthy Korean Volunteers
- ClinicalTrials.gov ID
- NCT01902342
- Acronym / sponsor ID
- CES1 / CES01
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 18 Jul 2013 (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.
Investigate genetic variability of CES1 gene on pharmacokinetics of oseltamivir in healthy Korean volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CES1 gene variant group | Experimental | Drug: Oseltamivir 75 mg 1 capOseltamivir 75 mg 1 cap |
| CES1 gene wild type group | Experimental | Drug: Oseltamivir 75 mg 1 capOseltamivir 75 mg 1 cap |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Agreement with written informed consent
- Adult healthy male or female subject age 20 to 45
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Oseltamivir 75 mg 1 capAlso: Tamiflu | Drug | CES1 gene variant group, CES1 gene wild type group |
Primary outcome
Oseltamivir pharmacokinetic parameters
Time frame: Up to 0 to 48 h post dose
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
Oseltamivir carboxylate pharmacokinetic parameters
Time frame: Up to 0 to 48 h post dose
Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUCinf)
2 secondary outcomes
Other oseltamivir pharmacokinetic parameters
Time frame: Up to 0 to 48 h post dose
Other oseltamivir carboxylate pharmacokinetic parameters
Time frame: Up to 0 to 48 h post dose
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 May 2014.
- Derived from this study: PubMed 28437488Oh 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.
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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.
Kyoung Soo Lim, 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 Oseltamivir 75 mg 1 cap in people with Healthy, 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 3 inclusion and 7 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 May 2014. 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?
Oseltamivir pharmacokinetic parameters (time frame: Up to 0 to 48 h post dose). 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?
On the ClinicalTrials.gov record for NCT01902342, which also lists 1 linked publication.
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 May 2014.