DyslipidemiasPhase 1NCT04874129
Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
A Phase 1 study testing YYC506-T and YYC506-A (phase 1), YYC506 (phase 1) and YYC506-T and YYC506-A (phase 2) in people with Dyslipidemias, run by Yooyoung Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A Read more about this study
- Who is it for?
- Ages 19 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- YYC506-T and YYC506-A (phase 1), YYC506 (phase 1) and YYC506-T and YYC506-A (phase 2)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2021to 31 Jul 2021
- 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 19 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Over 19 ages healthy men
- Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
- Men who don't have congenital disease and other cronic disease need to be cared. etc.
Who cannot join
- Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
- Men who have drunken or eatten something including caffeine within 24 hours before. etc.
Trial locations and contacts
1 site in 1 country.
About this study
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A
Read the detailed description
Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.
- Conditions
- Dyslipidemias
- Being tested
- YYC506-T and YYC506-A (phase 1), YYC506 (phase 1), YYC506-T and YYC506-A (phase 2), YYC506 (phase 2)
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYC506-T and YYC506-A (phase 1)Drug
Also called Comparator
Comparator
YYC506 (phase 1)Drug
Also called Test
Test
YYC506-T and YYC506-A (phase 2)Drug
Also called Comparator
Comparator
YYC506 (phase 2)Drug
Also called Test
Test
| Study group | Role | What they receive |
|---|---|---|
| A Group | Other | Two-way Crossover Receives: Drug: YYC506-T and YYC506-A (phase 1); Drug: YYC506 (phase 2) |
| B Group | Other | Two-way Crossover Receives: Drug: YYC506 (phase 1); Drug: YYC506-T and YYC506-A (phase 2) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters: Cmax
Cmax
Measured: Until 48 hours
Pharmacokinetic parameters: AUC
YYC506-T, YYC506-A, YYC506 AUC
Measured: Until 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2021
- Study start7 Jan 2021
- Primary completion31 May 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiasStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- ramdomized, open-label, single-dose, two-way crossover study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Min Kyu Park, PhD, Study chair, Chungbuk National University Hosipital.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04874129
- Sponsor's protocol ID
- YYPCT_YYC506_102
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 to Evaluate the Safety and Pharmacokinetic Characteristics of Fixed-dose Combination of YYC506
- ClinicalTrials.gov ID
- NCT04874129
- Acronym / sponsor ID
- YYPCT_YYC506_102
- Conditions
- Dyslipidemias
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 5 May 2021 (actual)
- 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.
To evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A
Detailed description
Phase 1 to evaluate the safety and pharmacokinetics characteristics between YYC506 and concomitant administration of YYC506-T and YYC506-A. Which is designed as ramdomized, oral, single dose, two-way crossover.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ramdomized, open-label, single-dose, two-way crossover study
| Arm | Type | Receives |
|---|---|---|
| A Group | Other | Drug: YYC506-T and YYC506-A (phase 1), Drug: YYC506 (phase 2)Two-way Crossover |
| B Group | Other | Drug: YYC506 (phase 1), Drug: YYC506-T and YYC506-A (phase 2)Two-way Crossover |
Who may qualify
- Ages
- 19 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Over 19 ages healthy men
- Over 50.0kg, 18.0kg/m2 ≤ BMI ≤ 30.0kg/m2
- Men who don't have congenital disease and other cronic disease need to be cared. etc.
Key exclusion criteria (2 listed)
- Men who have congenital liver disease (AST, ALT, CK ≥ 2X ULN)
- Men who have drunken or eatten something including caffeine within 24 hours before. etc.
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 |
|---|---|---|
| YYC506-T and YYC506-A (phase 1)Also: ComparatorComparator | Drug | A Group |
| YYC506 (phase 1)Also: TestTest | Drug | B Group |
| YYC506-T and YYC506-A (phase 2)Also: ComparatorComparator | Drug | B Group |
| YYC506 (phase 2)Also: TestTest | Drug | A Group |
Primary outcome
Pharmacokinetic parameters: Cmax
Time frame: Until 48 hours
Cmax
Pharmacokinetic parameters: AUC
Time frame: Until 48 hours
YYC506-T, YYC506-A, YYC506 AUC
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Individual participant dataSharing planned: No
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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.
Min Kyu Park, PhD study chair
Chungbuk National University Hosipital.
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 YYC506-T and YYC506-A (phase 1), YYC506 (phase 1) and YYC506-T and YYC506-A (phase 2) in people with Dyslipidemias, run by Yooyoung Pharmaceutical Co., Ltd. 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: status not confirmed, as of the sponsor's last update on 5 May 2021. 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?
Results are not available in the source record.
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?
Pharmacokinetic parameters: Cmax (time frame: Until 48 hours). 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?
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 5 May 2021.