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Healthy VolunteersPhase 1NCT02894541

Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519

A Phase 1 study testing CKD-519 100mg and CKD-519 200mg in people with Healthy Volunteers, 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
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Trial summary

The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519. 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
Healthy Volunteers
What is being tested?
CKD-519 100mg and CKD-519 200mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteSouth Korea
Study dates
Aug 2016to Jan 2017
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 adult male
  • Body weight more than 50, Body Mass Index between 18 and 29kg/m²
  • 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
  • Those who fully understand about this clinical trials after enough hearing, and then decided to join the clinical trials by themselves and to comply with the precautions written consent

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
  • Defined by the following 12-lead ECG, QTc>450msec
Show all 17Show fewer
  • Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))
  • 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
  • Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days
  • Continuously taking caffeine(caffeine>5 cups/day), drinking alcohol(alcohol>210g/week), smoking excessive cigarettes(cigarette>10cigarettes/day)
  • Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasons(for example, noncompliance, a disobliging manner)

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: A Randomized, Open-label, Single Dose, 1-sequence, 3-treatment, 3-period Crossover Study to Investigate the Effects of Food on the Pharmacokinetics/Pharmacodynamics of CKD-519 in Healthy Male Subjects

The purpose of this study is to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519.

Read the detailed description

A randomized, open-label, single dose, 1-sequence, 3-treatment, 3-period crossover study to investigate the effects of food on the pharmacokinetics/pharmacodynamics of CKD-519 in healthy male subjects.

Being tested
CKD-519 100mg, CKD-519 200mg
Keywords
Dyslipidemia, CKD-519, CETP inhibitor, Food Drug Interaction
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 100mgDrug

    Also called CKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab)

  • CKD-519 200mgDrug

    Also called CKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs)

  • CKD-519 100mgDrug

    Also called CKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap)

  • CKD-519 200mgDrug

    Also called CKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps)

Study groups in NCT02894541
Study groupRoleWhat they receive
CKD-519 tablet 100mgExperimentalCKD-519 tablet(formulation Ⅱ) 100mg(100mg X 1Tab) Period 1: CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
Receives: Drug: CKD-519 100mg
CKD-519 tablet 200mgExperimentalCKD-519 tablet(formulation Ⅱ) 200mg(100mg X 2Tabs) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
Receives: Drug: CKD-519 200mg
CKD-519 soft capsule 100mgExperimentalCKD-519 soft capsule(formulation Ⅲ) 100mg(100mg X 1Cap) Period 1:CKD-519 100mg in fasted state Period 2:CKD-519 100mg with a standard meal Period 3:CKD-519 100mg with a high fat meal
Receives: Drug: CKD-519 100mg
CKD-519 soft capsule 200mgExperimentalCKD-519 soft capsule(formulation Ⅲ) 200mg(100mg X 2Caps) Period 1:CKD-519 200mg in fasted state Period 2:CKD-519 200mg with a standard meal Period 3:CKD-519 200mg with a high fat meal
Receives: Drug: CKD-519 200mg

What is being measured

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

  1. Cmax of CKD-519

    Measured: 0(predose)~168

  2. AUClast of CKD-519

    Measured: 0(predose)~168

  3. Tmax of CKD-519

    Measured: 0(predose)~168

  4. AUCinf of CKD-519

    Measured: 0(predose)~168

  5. T1/2 of CKD-519

    Measured: 0(predose)~168

  6. CL/F of CKD-519

    Measured: 0(predose)~168

  7. Vd/F of CKD-519

    Measured: 0(predose)~168

Secondary outcomes (1)

  1. Inhibition of CETP(Cholesteryl ester transfer protein) Activity

    Measured: 0(predose)~168

Timeline

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

  1. First posted9 Sep 2016 (estimated)
  2. Study startAug 2016
  3. Primary completionNov 2016
  4. Study completionJan 2017

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
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02894541
Sponsor's protocol ID
148FDI16004
Status last verified
Aug 2016
First submitted
5 Sep 2016
Last updated
23 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-519 100mg and CKD-519 200mg in people with Healthy Volunteers, 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 17 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 23 Feb 2017. 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: 0(predose)~168). The study lists 7 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 NCT02894541.

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 23 Feb 2017.

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