HealthyPhase 1NCT00942773
Influence of CYP2C19 Genotype on the Pharmacokinetics (PK) of Voriconazole
A Phase 1 study testing Voriconazole in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to: Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole. Read more about this study
- Who is it for?
- Ages 20 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Voriconazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2008to Mar 2009
- 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 20 - 50 years.
- A body mass index (BMI) in the range 17-28 kg/m2.
- Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Who cannot join
- Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
- Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- Presence or history of eye disease or eye field defect.
- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
- A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
- A subject whose SBP is over 140 mmHg or below 90 mmHg and DBP is over 100 mmHg or below 50 mmHg.
Show all 14Show fewer
- Presence or history of drug abuse.
- Participation in other clinical trial within 2 months.
- Use of a prescription medicine, herbal medicine within 2 weeks or over-the-counter medication within 1 week before first dose.
- Blood donation during 2 months or apheresis during 1 month before the study.
- Presence or history of alcohol abuse.
- Smoking of more than 10 cigarettes/day.
- Use of grapefruit juice, xanthine containing beverage, alcohol or smoking during restriction period.
- Subject judged not eligible for study participation by investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Hospital Clinical Trial Center
Seoul, 110-744
About this study
Official title: Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part A)
The purpose of this study is to:
- Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
- Conditions
- Healthy
- Being tested
- Voriconazole
- Keywords
- Healthy volunteer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VoriconazoleDrug
| Study group | Role | What they receive |
|---|---|---|
| CYP2C19 extensive metabolizer | Active comparator | Not described Receives: Drug: Voriconazole |
| CYP2C19 heterozygous extensive metabolizer | Active comparator | Not described Receives: Drug: Voriconazole |
| CYP2C19 poor metabolizer | Active comparator | Not described Receives: Drug: Voriconazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of voriconazole
Secondary outcomes (4)
Adverse events collected by investigator questionnaire and subjects spontaneous report
12-lead ECG
Clinical laboratory test
Vital signs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2009 (estimated)
- Study startDec 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00942773
- Sponsor's protocol ID
- SNUCPT09_Vori2C19_A
- Status last verified
- Mar 2010
- First submitted
- 14 Jul 2009
- Last updated
- 4 Mar 2010
- Results posted
- No
Publications
Lee S, Gu N, Kim BH, Lim KS, Shin SG, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic properties of the calcimimetic agent cinacalcet (KRN1493) in healthy male Korean subjects: a randomized, open-label, single ascending-dose, parallel-group study. Clin Ther. 2012 May;34(5):1160-9. doi: 10.1016/j.clinthera.2012.03.058. Epub 2012 Apr 13.
PubMed 22503212Lee S, Kim BH, Nam WS, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Effect of CYP2C19 polymorphism on the pharmacokinetics of voriconazole after single and multiple doses in healthy volunteers. J Clin Pharmacol. 2012 Feb;52(2):195-203. doi: 10.1177/0091270010395510.
PubMed 21383338
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trials to Evaluate the Influence of CYP2C19 Genotype and Drug-drug Interactions on the Pharmacokinetics of Voriconazole in Healthy Korean Male Volunteers (Part A)
- ClinicalTrials.gov ID
- NCT00942773
- Acronym / sponsor ID
- SNUCPT09_Vori2C19_A
- Conditions
- Healthy
- Keywords
- Healthy volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 21 Jul 2009 (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:
- Evaluate the influence of CYP2C19 genotype on PK profiles of voriconazole.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CYP2C19 extensive metabolizer | Active comparator | Drug: Voriconazole |
| CYP2C19 heterozygous extensive metabolizer | Active comparator | Drug: Voriconazole |
| CYP2C19 poor metabolizer | Active comparator | Drug: Voriconazole |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy male subjects aged 20 - 50 years.
- A body mass index (BMI) in the range 17-28 kg/m2.
- Sufficient ability to understand the nature of the study and any hazards of participating in it. Provide written informed consent after being fully. informed about the study procedures.
Key exclusion criteria (14 listed)
- Presence or history of severe adverse reaction to any drug or a history of severe allergic disease.
- Clinically relevant abnormal medical history that could interfere with the objectives of the study.
- Presence or history of eye disease or eye field defect.
- A subject with history of gastrointestinal disease or surgery (except simple appendectomy or repair of hernia), which can influence the absorption of the study drug.
- A subject whose liver function test (AST, ALT, GGT, ALP, LDH) result is over 1.25 times of upper limit of normal range.
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 |
|---|---|---|
| Voriconazole | Drug | CYP2C19 extensive metabolizer, CYP2C19 heterozygous extensive metabolizer, CYP2C19 poor metabolizer |
Primary outcome
Plasma concentration of voriconazole
4 secondary outcomes
Adverse events collected by investigator questionnaire and subjects spontaneous report
12-lead ECG
Clinical laboratory test
Vital signs
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 4 Mar 2010.
- Derived from this study: PubMed 22503212Lee S, Gu N, Kim BH, Lim KS, Shin SG, Jang IJ, Yu KS. Pharmacokinetic and pharmacodynamic properties of the calcimimetic agent cinacalcet (KRN1493) in healthy male Korean subjects: a randomized, open-label, single ascending-dose, parallel-group study. Clin Ther. 2012 May;34(5):1160-9. doi: 10.1016/j.clinthera.2012.03.058. Epub 2012 Apr 13.
- Derived from this study: PubMed 21383338Lee S, Kim BH, Nam WS, Yoon SH, Cho JY, Shin SG, Jang IJ, Yu KS. Effect of CYP2C19 polymorphism on the pharmacokinetics of voriconazole after single and multiple doses in healthy volunteers. J Clin Pharmacol. 2012 Feb;52(2):195-203. doi: 10.1177/0091270010395510.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Voriconazole 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 14 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 4 Mar 2010. 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?
Plasma concentration of voriconazole. 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 NCT00942773, which also lists 2 linked publications.
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 4 Mar 2010.