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DyslipidemiaPhase 1NCT02484482

Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519(CKD-519 FDI)

A Phase 1 study testing CKD-519 200mg / Fasting, Standard Meal, High Fat Meal 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
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Trial summary

The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519 Read more about this study

Who is it for?
Ages 19 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Dyslipidemia
What is being tested?
CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteSouth Korea
Study dates
Jun 2015to Aug 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 19 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Between 19 aged and 55 aged in healthy adult
  • Body weight more than 55kg in male, 50kg in female
  • Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
  • If female, must include more than one among the items
  • The menopause(there is no natural menses for at least 2 years)
  • Surgical Infertility(hysterectomy or bilateral oophorectomy, tubal ligation or other methods of infertility condition)
  • If men has sexual life with women of childbearing age, Necessarily he agrees that use condoms 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

  • Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc.), kidney(severe renal impairment, etc.), nervous system, immune system, respiratory system, endocrine system, haemato-oncology disease, cardiovascular system(heart failure, etc.) or mental illness, or a history of mental disease.
  • Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
  • Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
  • An impossible one who participates in clinical trial including screening tests (medical history taking, BP, 12-lead ECG, physical examination, blood\&urine laboratory test result) before 28 days the taking investigational products.
  • Defined by the following laboratory parameters
  • AST(Aspartate aminotransferase), ALT(Alanine aminotransferase)>1.25* upper limit of normal range
Show all 20Show fewer
  • Total bilirubin>1.5* upper limit of normal range
  • CPK(Creatine phosphokinase)>1.5* upper limit of normal range
  • eGFR(Estimated Glomerular Filtration Rate, using by MDRD(Modification of Diet in Renal Disease) method)<60 mL/min/1.73m2
  • Sitting SBP(Systolic Blood Pressure )>150 mmHg or <90 mmHg, sitting DBP(Diastolic Blood Pressure )>100 mmHg or 50 mmHg , after 5 minutes break.
  • Drug abuse or have a history of drug abuse shows a positive for urine drug test.
  • Pregnant or lactating women.
  • A heavy caffeine consumer(caffeine>5 cups/day), alcohol consumer(alcohol>210g/week), or smoker(cigarette>10 cigarettes/day)
  • Subject takes ethical drug or herbal medicine within 14 days, OTC(Over The Counter Drug) within 7 days before the beginning of study treatment but investigator determine that the taking drug affect this study or could affect the safety of subjects
  • Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30days.
  • Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1 liter per a day or more within 7days before the beginning of study treatment)
  • Subject who treated with any investigational drugs within 90 days before the beginning of study treatment.
  • Previously donate whole blood within 60 days or component blood within 30days.
  • An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason.
  • Positive for Serology test(Hepatitis B, Hepatitis C, HIV)

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Severance Hospital

    Seoul, Seodaemun-gu, 120-752

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Dose, 3-treatment, 3-period, 6-sequence Crossover Study to Investigate the Effect of Food on the Pharmacokinetics/Pharmacodynamics and Safety of CKD-519 After Oral Administration in Healthy Adult Volunteers

The purpose this study investigate the effect of food on the pharmacokinetics/pharmacodynamics and safety of CKD-519

Conditions
Dyslipidemia
Being tested
CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
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 200mg / Fasting, Standard Meal, High Fat MealDrug

Study groups in NCT02484482
Study groupRoleWhat they receive
Group 1ExperimentalCKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→Standard Meal→High Fat Meal
Receives: Drug: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 2ExperimentalCKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Standard Meal→High Fat Meal→Fasting
Receives: Drug: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 3ExperimentalCKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. High Fat Meal→Fasting→Standard Meal
Receives: Drug: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 4ExperimentalCKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Fasting→High Fat Meal→Standard Meal
Receives: Drug: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 5ExperimentalCKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. Standard Meal→Fasting→High Fat Meal
Receives: Drug: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal
Group 6ExperimentalCKD-519 200mg administration, subjects have a Fasting, Standard Meal, High Fat Meal by randomized group. High Fat Meal→Standard Meal→Fasting
Receives: Drug: CKD-519 200mg / Fasting, Standard Meal, High Fat Meal

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), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  2. Area under the plasma drug concentration-time curve(AUC0-last) of CKD-519

    Measured: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  3. AUC0-∞ of CKD-519

    Measured: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  4. Tmax of CKD-519

    Measured: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  5. T1/2 of CKD-519

    Measured: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  6. CL/F(Clearance/Bioavailability) of CKD-519

    Measured: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

  7. Vd/F of CKD-519

    Measured: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

Secondary outcomes (1)

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

    Measured: 0(predose), 1, 2, 4, 6, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 168

Timeline

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

  1. First posted29 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionAug 2015
  4. Study completionAug 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
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02484482
Sponsor's protocol ID
148FDI15009
Status last verified
Dec 2015
First submitted
7 Jun 2015
Last updated
7 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CKD-519 200mg / Fasting, Standard Meal, High Fat Meal 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 8 inclusion and 20 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 7 Dec 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?

Cmax of CKD-519 (time frame: 0(predose), 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 18, 24, 32, 48, 72, 96, 120, 144, 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 NCT02484482.

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 7 Dec 2015.

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