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AzTrials

DyslipidemiaPhase 1NCT02623868

Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.

A Phase 1 study testing CKD-519 50mg 2Tabs., CKD-519 100mg 1Tab. and CKD-519 100mg 1Cap. in people with Dyslipidemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects. Read more about this study

Who is it for?
Ages 20 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dyslipidemia
What is being tested?
CKD-519 50mg 2Tabs., CKD-519 100mg 1Tab. and CKD-519 100mg 1Cap.
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteSouth Korea
Study dates
Oct 2015to Dec 2015
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
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between 20 aged and 45 aged in healthy male adult
  • Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18~29kg/m2
  • Subject who sign on an informed consent form willingly
  • Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products

Who cannot join

  • Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system
  • Have a acute disease within 28 days before the beginning of study treatment
  • Have a disease history that can effect drug absorption, distribution, metabolism, excretion
  • Have a clinically significant chronic disease
  • Systolic blood pressure <100mmHg or >140mmHg, diastolic blood pressure<60mmHg or >90mmHg
  • Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
Show all 16Show fewer
  • Subject treated ethical drug within 14 days before the beginning of study treatment
  • Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment
  • Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)
  • Cannot take standard Meal
  • Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing
  • Blood transfusion within 30 days
  • Taking drugs have received any other investigational drug within 90 days prior to the first dosing
  • Continuously taking caffeine(>5 cups/day), drinking alcohol(>30g/day), smoking excessive cigarettes(>10cigarettes/day)
  • Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)
  • Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Korea university medical center

    Seoul, Sungbuk-gu, 136-705

Other trials in South Korea

About this study

Official title: Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subjects

Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.

Read the detailed description

Open-label, Randomized, 3-period, 6-sequence, crossover study

Conditions
Dyslipidemia
Being tested
CKD-519 50mg 2Tabs., CKD-519 100mg 1Tab., CKD-519 100mg 1Cap.
Medical subject headings
Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CKD-519 50mg 2Tabs.Drug

    Also called Drug A

    after taking Standard meal, CKD-519 50mg 2Tabs. administration.

  • CKD-519 100mg 1Tab.Drug

    Also called Drug B

    after taking Standard meal, CKD-519 100mg 1Tab. administration.

  • CKD-519 100mg 1Cap.Drug

    Also called Drug C

    after taking Standard meal, CKD-519 100mg 1Cap. administration.

Study groups in NCT02623868
Study groupRoleWhat they receive
Group 1ExperimentalA-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Receives: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.
Group 2ExperimentalB-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Receives: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.
Group 3ExperimentalC-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Receives: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.
Group 4ExperimentalA-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Receives: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.
Group 5ExperimentalB-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Receives: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.
Group 6ExperimentalC-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)
Receives: Drug: CKD-519 50mg 2Tabs.; Drug: CKD-519 100mg 1Tab.; Drug: CKD-519 100mg 1Cap.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  2. Tmax of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  3. AUClast of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  4. AUC0-∞ of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  5. t1/2 of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  6. CL/F of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  7. Vd/F of CKD-519

    Measured: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h

  8. Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity

    Measured: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  9. Tmax of CKD-519 CETP Activity

    Measured: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  10. AUEC of CKD-519 CETP Activity

    Measured: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

  11. EC50(half maximal effective concentration ) of CKD-519 CETP Activity

    Measured: 0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2015 (estimated)
  2. Study startOct 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02623868
Sponsor's protocol ID
148NF15010
Status last verified
Jan 2016
First submitted
23 Oct 2015
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-519 50mg 2Tabs., CKD-519 100mg 1Tab. and CKD-519 100mg 1Cap. in people with Dyslipidemia, run by Chong Kun Dang Pharmaceutical 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 4 inclusion and 16 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 Jan 2016. 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?

Cmax of CKD-519 (time frame: 0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h). The study lists 11 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 NCT02623868.

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 Jan 2016.

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