Pharmacokinetics of Three PDE5IsPhase 1CYP3APDE5INCT00767598
The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors in Male Subjects
A Phase 1 study testing phosphodiesterase type 5 inhibitor in people with Pharmacokinetics of Three PDE5Is and Healthy Subjects, run by Inje University.
Trial summary
In order to evaluate the effect of CYP3A5*3 allele on the pharmacokinetics of sildenafil, udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined. Read more about this study
- Who is it for?
- Ages 20 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics of Three PDE5Is, Healthy Subjects, Genetic Polymorphic CYP3A5
- What is being tested?
- phosphodiesterase type 5 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Jul 2008
- 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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male subject whose CYP3A5 genotype was determined
Who cannot join
- Subject whose CYP3A5 genotype was not determined
About this study
Official title: The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects
In order to evaluate the effect of CYP3A5*3 allele on the pharmacokinetics of sildenafil, udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined.
Read the detailed description
The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokinetics(PK) of sildenafil, udenafil, and vardenafil in healthy male subjects. Twenty one healthy male subjects with CYP3A5*1/*1, *1/*3, or *3/*3 were enrolled. An open-label 3-way crossover study was performed with a week washout. A single oral dose of PDE5I (100 mg sildenafil; 200 mg udenafil; 20 mg vardenafil) was administered, respectively. After a single oral dose of phosphodiesterase type 5 inhibitor (PDE5I), plasma levels of the parent and the major metabolite were measured up to 24 or 48 h.
- Being tested
- phosphodiesterase type 5 inhibitor
- Keywords
- CYP3A5, sildenafil, udenafil, vardenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phosphodiesterase type 5 inhibitorDrug
Also called vardenafil
single oral administration of 20mg vardenafil
phosphodiesterase type 5 inhibitorDrug
Also called sildenafil
single oral administration of 100mg sildenafil
phosphodiesterase type 5 inhibitorDrug
Also called udenafil
single oral administration of 200mg udenafil
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Vardenafil Receives: Drug: phosphodiesterase type 5 inhibitor |
| B | Active comparator | Sildenafil Receives: Drug: phosphodiesterase type 5 inhibitor |
| C | Active comparator | Udenafil Receives: Drug: phosphodiesterase type 5 inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax, AUC
Measured: upto 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2008 (estimated)
- Study startDec 2007
- Primary completionDec 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pharmacokinetics of Three PDE5IsStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inje University
- Sponsor type
- University, hospital or other
- Investigators
- Jae-Gook Shin, Principal investigator, Inje University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00767598
- Sponsor's protocol ID
- 07-109
- Acronym
- CYP3APDE5I
- Status last verified
- Jul 2008
- First submitted
- 6 Oct 2008
- Last updated
- 7 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of CYP3A Genetic Polymorphism on the Pharmacokinetics of Phosphodiesterase type5 Inhibitors(PDE5I) in Male Subjects
- ClinicalTrials.gov ID
- NCT00767598
- Acronym / sponsor ID
- CYP3APDE5I / 07-109
- Keywords
- CYP3A5, sildenafil, udenafil, vardenafil
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Inje UniversityUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 7 Oct 2008 (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.
In order to evaluate the effect of CYP3A5*3 allele on the pharmacokinetics of sildenafil, udenafil, and vardenafil, the clinical trial using a single oral dose was conducted in Korean healthy male subjects whose genotype of CYP3A5 had been determined.
Detailed description
The aim of this study is to evaluate the different effect of the CYP3A5 genotype on the pharmacokinetics(PK) of sildenafil, udenafil, and vardenafil in healthy male subjects. Twenty one healthy male subjects with CYP3A5*1/*1, *1/*3, or *3/*3 were enrolled. An open-label 3-way crossover study was performed with a week washout. A single oral dose of PDE5I (100 mg sildenafil; 200 mg udenafil; 20 mg vardenafil) was administered, respectively. After a single oral dose of phosphodiesterase type 5 inhibitor (PDE5I), plasma levels of the parent and the major metabolite were measured up to 24 or 48 h.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: phosphodiesterase type 5 inhibitorVardenafil |
| B | Active comparator | Drug: phosphodiesterase type 5 inhibitorSildenafil |
| C | Active comparator | Drug: phosphodiesterase type 5 inhibitorUdenafil |
Who may qualify
- Ages
- 20 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy male subject whose CYP3A5 genotype was determined
Key exclusion criteria (1 listed)
- Subject whose CYP3A5 genotype was not determined
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 |
|---|---|---|
| phosphodiesterase type 5 inhibitorAlso: vardenafilsingle oral administration of 20mg vardenafil | Drug | A |
| phosphodiesterase type 5 inhibitorAlso: sildenafilsingle oral administration of 100mg sildenafil | Drug | B |
| phosphodiesterase type 5 inhibitorAlso: udenafilsingle oral administration of 200mg udenafil | Drug | C |
Primary outcome
Cmax, AUC
Time frame: upto 24hours
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 7 Oct 2008.
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.
Jae-Gook Shin principal investigator
Inje University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing phosphodiesterase type 5 inhibitor in people with Pharmacokinetics of Three PDE5Is and Healthy Subjects, run by Inje University.
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 1 inclusion and 1 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 7 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
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?
Cmax, AUC (time frame: upto 24hours). 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 7 Oct 2008.