HealthyPhase 4NCT01514019
An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
A Phase 4 study testing Acebutolol in people with Healthy, run by In-Jin Jang, MD, PhD at 2 sites in 2 countries.
Trial summary
An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Acebutolol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to May 2012
- Phase
- Phase 4
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
Who cannot join
- A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
- Conditions
- Healthy
- Being tested
- Acebutolol, Placebo
- Keywords
- SLCO2B1 genotype, effect of apple juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcebutololDrug
Also called Acebutolol 200 mg capsule (Acetanol®)
Acebutolol
PlaceboDrug
Also called Placebo capsule(Capsules filled up with lactose)
Placebo capsule(Capsules filled up with lactose)
| Study group | Role | What they receive |
|---|---|---|
| Acebutolol | Experimental | Acebutolol 200 mg capsule (Acetanol®) Receives: Drug: Acebutolol |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC of acebutolol according to the SLCO2B1 genotypes
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics.
Measured: 0-24 hr after drug administration
Secondary outcomes (1)
Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes
Blood pressure (systolic, diastolic) measurement will be presented as descriptive statistics for the difference from baseline where appropriate.
Measured: 0-24 hr after drug admnistration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- In-Jin Jang, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Oita University, Seoul National University Hospital, Kyushu University
- Responsible party
- Sponsor-investigator, In-Jin Jang, MD, PhD, Seoul National University Hospital
- Investigators
- Kyoichi Ohashi, MD, PhD, Study chair, Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514019
- Sponsor's protocol ID
- 2012_Acebutolol
- Status last verified
- Jun 2012
- First submitted
- 17 Jan 2012
- Last updated
- 20 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-dose, Two-treatment, Randomized, Cross-over Study to Investigate the Effects of the SLCO2B1 c.1457C>T Polymorphism and Apple Juice on the Pharmacokinetics and Pharmacodynamics of Acebutolol in Healthy Korean and Japanese Volunteers
- ClinicalTrials.gov ID
- NCT01514019
- Acronym / sponsor ID
- 2012_Acebutolol
- Conditions
- Healthy
- Keywords
- SLCO2B1 genotype, effect of apple juice
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- In-Jin Jang, MD, PhDUniversity, hospital or other
- Collaborators
- Oita University, Seoul National University Hospital, Kyushu University
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 20 Jan 2012 (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.
An open-label, single-dose, two-treatment, randomized, cross-over study to investigate the effects of the SLCO2B1 c.1457C>T polymorphism and apple juice on the pharmacokinetics and pharmacodynamics of acebutolol in healthy Korean and Japanese volunteers
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acebutolol | Experimental | Drug: AcebutololAcebutolol 200 mg capsule (Acetanol®) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and signs an Institutional Review Board (IRB) - approved informed consent prior to performing any of the screening procedures
Key exclusion criteria (1 listed)
- A subject with history of allergies including study drug (acebutolol) or other drug allergies (aspirin, antibiotics, etc.), or history of clinically significant allergies
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 |
|---|---|---|
| AcebutololAlso: Acebutolol 200 mg capsule (Acetanol®)Acebutolol | Drug | Acebutolol |
| PlaceboAlso: Placebo capsule(Capsules filled up with lactose)Placebo capsule(Capsules filled up with lactose) | Drug | Placebo |
Primary outcome
AUC of acebutolol according to the SLCO2B1 genotypes
Time frame: 0-24 hr after drug administration
The area under the plasma concentration versus time curve, from time 0 to the last measurable concentration, as calculated by the linear/log trapezoidal method will be summarized by treatment and genotype group using descriptive statistics.
1 secondary outcome
Blood pressure of the subjects who administered acebutolol according to the SLCO2B1 genotypes
Time frame: 0-24 hr after drug admnistration
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 20 Jun 2012.
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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.
Kyoichi Ohashi, MD, PhD study chair
Department of Clinical Pharmacology and Therapeutics, Oita University Faculty of Medicine, Oita, Japan
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Acebutolol in people with Healthy, run by In-Jin Jang, MD, PhD at 2 sites in 2 countries.
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 20 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan, 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. Some participants in this study may receive a placebo. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 of acebutolol according to the SLCO2B1 genotypes (time frame: 0-24 hr after drug administration). 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 20 Jun 2012.