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DyslipidemiasPhase 1NCT03346187

A Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337

A Phase 1 study testing Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate) and Test drug(CKD-337) in people with Dyslipidemias, 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

A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetic characteristics of CKD-337 in healthy male volunteers Read more about this study

Who is it for?
Ages 19 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Dyslipidemias
What is being tested?
Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate) and Test drug(CKD-337)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSouth Korea
Study dates
19 May 2017to 13 Jun 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 19 to 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy male older than 19 years and under 45 years at the time of screening
  • BMI 17.5~30.5 kg/m² and body weight more than 55kg
  • BMI = Weight(kg)/{Height(m)}²
  • Subject who is no chronic disease, no symptoms or pathological findings
  • Suitable subject who is determined by laboratory tests(hematology test, blood chemistry, urinalysis test etc.), Vital Sign, ECG test at the time of screening
  • Subject who fully understand the clinical trials after in-depth explanation, decide to join the clinical trials and sign on an inform consent from willing

Who cannot join

  • Subject who has a clinically significant disease such as hepatic, kidneys, neurological, respiratory, endocrine, hemato-oncology, urinary, cardiovascular, musculoskeletal or psychiatric diseases and who has a following history
  • Gallbladder disease including cholelithiasis, severe hepatic impairment
  • Acute/chronic pancreatitis due to hypertriglyceridemia
  • Pulmonary embolism or interstitial lung disease
  • Genetic problems such as galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Hypoalbuminemia
Show all 31Show fewer
  • Alcoholics
  • Predisposition to rhabdomyolysis
  • Subject who has a history of gastrointestinal disease or gastrointestinal surgery which can affect drug absorption
  • Subject who has hypersensitivity to the drug composition containing choline fenofibrate, fenofibrate or atorvastatin, and other drug(aspirin, fenofibrate series, antibiotic and so on)
  • The following clinical significant findings in the EKG at the time of screening
  • QTc(Q-T interval corrected for heart rate) > 450ms
  • PR interval(The interval between the beginning of the P wave and the beginning of the QRS complex in ECG) > 200msec
  • QRS duration(The duration of the Q,R and S wave in ECG) > 120msec
  • The following results in the clinical laboratory tests
  • CPK(Creatinine Phospho-Kinase) > 2 x upper limit of normal range
  • Liver function test(AST; Aspartate Transaminase, ALT; Alanine Transaminase, ALP; Alkaline phosphatase, Total bilirubin, γ-GT) > 2 x upper limit of normal range
  • eGFR(Estimated Glomerular Filtration Rate) < 60 mL/min/1.73m² Calculated by MDRD(Modification of Diet in Renal Disease)
  • Systolic blood pressure ≥ 160mmHg(millimeter of mercury) or ≤ 100mmHg(millimeter of mercury) , Diastolic blood pressure ≥ 95mmHg(millimeter of mercury) or ≤ 60mmHg(millimeter of mercury) at the time of screening
  • History of drug abuse or a positive reaction for drug abuse in the urine at the time of screening
  • Taking medicines that are known to significantly induce or inhibit drug metabolizing enzymes, including barbiturates, within 30 days of the first dosing
  • Those who experience photoallergy or phototoxicity during treatment with fibrates or ketoprofen
  • Taking ETC(Ethical Drug), oriental medicine within 2 weeks and OTC(Over-the-counter Drug), vitamin within 10 days before the first dosing
  • Taking the medication involved in other clinical trials within 3 months before the first dosing
  • Whole blood donation with 2 months, component blood donation or blood transfusion within 1 month before the first dosing
  • Alcohol > 21 units/week (1unit=10g of pure alcohol), continuously within 6 month before the first dosing or Who can not stop drinking alcohol during the clinical trial
  • Smoker(> 10 cigarettes/day) for the last 3 months or who can not stop smoking during the clinical trial
  • Consumption of food containing grapefruit within 48 hours before first dosing and who can not stop consumption it until EOS(End of study)
  • Consumption of food containing caffeine(e.g. coffee, green tea etc.) within 24 hours before first dosing and who can not stop consumption it until discharge
  • Not using a reliable contraception or planning a pregnancy during the clinical trial
  • Unsuitable Conditions including laboratory result by investigator's judgement

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Dong-A University Hospital

    Busan, Seo-gu, 602-812

Other trials in South Korea

About this study

Official title: A Randomized, Open-label, Single Oral Dose, 2-way Crossover Clinical Trial to Compare Safety and Pharmacokinetic Characteristics of CKD-337 in Healthy Male Volunteers

A randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetic characteristics of CKD-337 in healthy male volunteers

Read the detailed description

This study is a randomized, open-label, single oral dose, 2-way crossover clinical trial to compare safety and pharmacokinetics of CKD-337 in healthy male volunteers.

Subjects will receive either a single oral dose of the test formulation(CKD-337) or a oral dose of the reference formulation(Atorvastatin Calcium Trihydrate+Fenofibrate).

Each treatment period was separated by a washout period of at least 7 days.

Conditions
Dyslipidemias
Being tested
Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), Test drug(CKD-337)
Medical subject headings
Dyslipidemias

What participants receive

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

  • Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)Drug

    Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)

  • Test drug(CKD-337)Drug

    CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)

Study groups in NCT03346187
Study groupRoleWhat they receive
AExperimentalPeriod 1: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions. Period 2: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions.
Receives: Drug: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate); Drug: Test drug(CKD-337)
BExperimentalPeriod 1: test drug(CKD-337 : Atorvastatin Calcium Trihydrate + Fenofibrate), 1 capsule administered under fed conditions. Period 2: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate), 2 tablets administered under fed conditions.
Receives: Drug: Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate); Drug: Test drug(CKD-337)

What is being measured

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

  1. Atorvastatin AUCt(Area under the plasma drug concentration-time curve)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration]

  2. Atorvastatin Cmax(Maximum plasma concentration)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  3. Fenofibric acid AUCt

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

  4. Fenofibric acid Cmax

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

Secondary outcomes (17)

  1. Atorvastatin AUCinf(Area under plasma concentration-time curve from time point of administration to infinite)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  2. Atorvastatin Tmax(Time taken to reach the maximum concentration)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  3. Atorvastatin t1/2(Terminal half-life, Time for Cmax to drop in half)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  4. Atorvastatin CL/F(Apparent total body clearance after extravascular administration, calculated as Dose/AUC)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  5. Atorvastatin Vd/F(Apparent volume of distribution/Bioavailability)

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  6. Fenofibric acid AUCinf

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

  7. Fenofibric acid Tmax

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

  8. Fenofibric acid t1/2

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

  9. Fenofibric acid CL/F

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

  10. Fenofibric acid Vd/F

    Measured: Predose(0hr), 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96hr after drug administration

  11. 2-hydroxy atorvastatin AUCt

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  12. 2-hydroxy atorvastatin Cmax

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  13. 2-hydroxy atorvastatin AUCinf

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  14. 2-hydroxy atorvastatin Tmax

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  15. 2-hydroxy atorvastatin t1/2

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  16. 2-hydroxy atorvastatin CL/F

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

  17. 2-hydroxy atorvastatin Vd/F

    Measured: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration

Timeline

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

  1. First posted17 Nov 2017
  2. Study start19 May 2017
  3. Primary completion31 May 2017
  4. Study completion13 Jun 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
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03346187
Sponsor's protocol ID
146BE16007
Status last verified
Dec 2017
First submitted
15 Nov 2017
Last updated
19 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate) and Test drug(CKD-337) in people with Dyslipidemias, 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 6 inclusion and 31 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 19 Dec 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?

Atorvastatin AUCt(Area under the plasma drug concentration-time curve) (time frame: Predose(0hr), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48hr after drug administration]). The study lists 4 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 NCT03346187.

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 19 Dec 2017.

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