HealthyPhase 1NCT02286934
Cytochrome P450 2D6 Genotype on the Clinical Effect of Carvedilol
A Phase 1 study testing Carvedilol and Isoproterenol Sensitivity Test in people with Healthy, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol 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?
- Carvedilol and Isoproterenol Sensitivity Test
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2014to Dec 2014
- 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 aged 20 - 45 years
- A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
- 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 hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
- Subject judged not eligible for study participation by investigator.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital
Seongnam, Gyounggi
About this study
Official title: A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers
A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol
Read the detailed description
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol
- Conditions
- Healthy
- Being tested
- Carvedilol, Isoproterenol Sensitivity Test
- Keywords
- Carvedilol, CYP2D6, Isoproterenol Sensitivity Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarvedilolDrug
- Day 1 to 3 : Carvedilol 12.5 mg qd
- Day 4 to 8 : Carvedilol 25 mg qd
- Day 9 to 11 : Carvedilol 12.5 mg qd
Isoproterenol Sensitivity TestOther
Day 0, 1, 8 : Isoproterenol Sensitivity Test
| Study group | Role | What they receive |
|---|---|---|
| Carvedilol | Experimental | * Day 1 to 3 : Carvedilol 12.5 mg qd
* Day 4 to 8 : Carvedilol 25 mg qd
* Day 9 to 11 : Carvedilol 12.5 mg qd
Isoproterenol Sensitivity Test
* Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes.
* Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes.
Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol. Receives: Drug: Carvedilol; Other: Isoproterenol Sensitivity Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC (area under the plasma concentration-time curve) of carvedilol
Measured: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Cmax (Maximum plasma concentration) of carvedilol
Measured: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2014 (estimated)
- Study startSep 2014
- Primary completionNov 2014
- Study completionDec 2014
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Food and Drug Safety Evaluation, Korea
- Responsible party
- Principal investigator, Jae Yong Chung, Seoul National University Hospital
- Investigators
- Jae-Yong Chung, MD, PhD, Principal investigator, Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286934
- Sponsor's protocol ID
- CYP-CVDL-01
- Status last verified
- Jun 2015
- First submitted
- 5 Sep 2014
- Last updated
- 4 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Jung E, Ryu S, Park Z, Lee JG, Yi JY, Seo DW, Lee J, Jeong HS, Kim JM, Oh WY. Influence of CYP2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamic Characteristics of Carvedilol in Healthy Korean Volunteers. J Korean Med Sci. 2018 May 23;33(27):e182. doi: 10.3346/jkms.2018.33.e182. eCollection 2018 Jul 2.
PubMed 29962926
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial to Investigate the Influence of Cytochrome P450 2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamics Characteristics of Carvedilol in Healthy Korean Volunteers
- ClinicalTrials.gov ID
- NCT02286934
- Acronym / sponsor ID
- CYP-CVDL-01
- Conditions
- Healthy
- Keywords
- Carvedilol, CYP2D6, Isoproterenol Sensitivity Test
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- National Institute of Food and Drug Safety Evaluation, Korea
- Study start
- Sep 2014
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 10 Nov 2014 (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.
A Clinical Study to Evaluate the Effect of Cytochrome P450 2D6 polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Carvedilol
Detailed description
This study has an open-label, one-sequence, multiple drug administration design. The purpose of this study is as follows;
To evaluate the change of the result of Isoproterenol Sensitivity Test according to Cytochrome P450 2D6 genotype after the multiple administration of carvedilol
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carvedilol | Experimental | Drug: Carvedilol, Other: Isoproterenol Sensitivity Test* Day 1 to 3 : Carvedilol 12.5 mg qd * Day 4 to 8 : Carvedilol 25 mg qd * Day 9 to 11 : Carvedilol 12.5 mg qd Isoproterenol Sensitivity Test * Day 0, 1.5h post-dose Injection of isoproterenol 4 times (0.25, 0.5, 1, 2 ug/mL), time interval of 10 minutes. * Day 1, 8, 1.5h post-dose Injection of isoproterenol 4 times (5, 10, 20, 40 ug/mL), time interval of 10 minutes. Measure change of heart rates after 1, 2, 3 minutes post injection of isoproterenol. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy Subjects aged 20 - 45 years
- A body mass index (BMI) in the range 18.0 kg/m2 (inclusive) - 27.0 kg/m2 (inclusive).
- 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 (2 listed)
- Presence or history of hypersensitivity or allergic reactions to drugs including investigational product (Carvedilol, Isoproterenol).
- Subject judged not eligible for study participation by investigator.
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 |
|---|---|---|
| Carvedilol* Day 1 to 3 : Carvedilol 12.5 mg qd * Day 4 to 8 : Carvedilol 25 mg qd * Day 9 to 11 : Carvedilol 12.5 mg qd | Drug | Carvedilol |
| Isoproterenol Sensitivity TestDay 0, 1, 8 : Isoproterenol Sensitivity Test | Other | Carvedilol |
Primary outcome
AUC (area under the plasma concentration-time curve) of carvedilol
Time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
Cmax (Maximum plasma concentration) of carvedilol
Time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose
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 Jun 2015.
- Derived from this study: PubMed 29962926Jung E, Ryu S, Park Z, Lee JG, Yi JY, Seo DW, Lee J, Jeong HS, Kim JM, Oh WY. Influence of CYP2D6 Polymorphism on the Pharmacokinetic/Pharmacodynamic Characteristics of Carvedilol in Healthy Korean Volunteers. J Korean Med Sci. 2018 May 23;33(27):e182. doi: 10.3346/jkms.2018.33.e182. eCollection 2018 Jul 2.
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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.
Jae-Yong Chung, MD, PhD principal investigator
Department of Clinical Pharmacology and Therapeutics, Seoul National University Bundang Hospital, Seongnam, Kore
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 Carvedilol and Isoproterenol Sensitivity Test 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 2 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 Jun 2015. 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?
AUC (area under the plasma concentration-time curve) of carvedilol (time frame: predose and 0.25, 0.5, 1, 2, 3, 4, 6, 12, 24h postdose). 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 NCT02286934, 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 4 Jun 2015.