Clinical trial NCT04627207: A Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of CKD-333 or Co-administration of CKD-333 and D085 in Healthy Volunteers
Official title: A Randomized, Open, Single-dose, 3 Period Partial Replicated Crossover-design Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics After Administration of CKD-333 or Co-administration of CKD-330 and D085 in Healthy Volunteers Under Fasting Conditions
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Cardiovascular Diseases
Keywords: CKD-333
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-11-13
Enrollment: 51
Sex: ALL
Minimum age (years): 19
Maximum age (years): 54
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A clinical trial to evaluate the safety and pharmacokinetic characteristics of CKD-333 or Co-administration of CKD-333 and D085 in healthy volunteers

Detailed description: A randomized, open, single-dose, 3 period partial replicated crossover-design clinical trial to evaluate the safety and pharmacokinetic characteristics after administration of CKD-333 or co-administration of CKD-330 and D085 in healthy volunteers under fasting conditions

Eligibility criteria: Inclusion Criteria:

* Healthy adult volunteers aged 19≤ \~ \<55-year-old.
* Those who have body weight ≥ 55kg (men) or ≥ 45kg (women), with calculated body mass index(BMI) of 17.5 ≤ \~ \< 30.5 kg/m2
* Those who have no congenital/chronic diseases, abnormal symptoms.
* Those who were deemed to eligible for participation of clinical trial by laboratory tests, vital signs and 12-lead ECG etc.
* Those who voluntarily decide to participate and agree to comply with the cautions and fully understanding the detailed description of this clinical trial.
* Those who consent to proper contraception during the study period and do not donate sperm until 14 days after the last administration of investigational product. And those who consent not to become pregnant or breastfeeding.
* Those who have ability and willingness to participate in clinical trial

Exclusion Criteria:

* Those who have medical history or medical symptom of liver, kidney, nervous system, respiratory system, digestive system, endocrine system, blood/tumor, urinary system, cardiovascular system, musculoskeletal disease, or mental disease.
* Those who have past medical history of gastrointestinal disorder (Crohn's disease, ulcerative colitis, etc. except simple appendectomy or hernia surgery), which affect the absorption of drug.
* Those who have the test results written below,

  * AST or ALT are 2 times higher than upper normal range
  * Creatinine is upper normal range or eGFR (estimated Glomerular Filtration Rate, which is calculated by MDRD) \< 60 mL/min/1.73m2
  * QTc is higher than 450msec measured by 12-lead ECG
  * CPK is 3 times higher than upper normal range
  * Serum Potassium is higher than 5.5 mEq/L
  * Hematocrit is under normal range
* Those who exceed alcohol consumption criteria (21 units/week within 3 months) prior to first administration of investigational product. Or Those who can't quit drinking alcohol from 48 hours to end of bleeding time point.
* Those who exceed smoke criteria (20 cigarettes/day within 6 months) prior to first administration of investigational product. Or Those who can't quit smoking during hospitalization.
* Those who have participated in other clinical trial and received Investigational product within 6 month prior to the first administration of drug.
* Those who have the test results written below,

  * Systolic blood pressure ≥140 mmHg or \<90 mmHg
  * Diastolic blood pressure ≥90 mmHg or \<60 mmHg
* Those who have a drug abuse history within one year prior to first administration of investigational product or positive reaction on urine drug screening test.
* Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of investigational product.
* Those who received following drugs, which may affect results of clinical trial and safety.

  * Ethical-the-counter (ETC) drugs or Over-the-counter (OTC) drugs within 10 days before the first administration of the investigational drug (especially Glecaprevir, Pibrentasvir).
* Those who donated whole blood within 2 months or apheresis within 1 month or received transfusion within 1 month.
* Those who have history of hypersensitivity to active pharmaceutical ingredient or Dihydropyridine or Aspirin, antibiotics etc.
* Those who deemed to ineligible for participation of clinical trial,

  * Patient with hyperkalemia
  * Patients with hepatopathy
  * Patients with hereditary angioedema, ACE inhibitors or angiotensin II receptor antagonists who have a history of angioedema
  * Primary hyperaldosteronism
  * Patients with aortic valve stenosis, mitral (valve) stenosis, hypertrophic obstructive cardiomyopathy
  * Patients with ischemic heart disease, ischemic cardiovascular disease, cerebrovascular disease
  * Patients with Intravascular volume depletion
  * Patients with diabetes or kidney failure
  * Patients with renal artery stenosis
  * Patients with muscle disease
  * Patients with Hypothyroidism
  * Patients with a history of muscle toxicity when using statins or fibrates
  * Patients who have recently had a kidney transplant
  * Patients with history of shock
* Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.
* Those who took caffeine or grapefruit within 3 months(5 cups/day) (before the first administration of investigational product) and can't stop taking caffeine or grapefruit until the end of clinical trial.
* Those who can't eat standard meal during hospitalization.
* Those who are pregnant or breastfeeding.
* Those who are deemed to ineligible for participation of clinical trial by investigators.

Primary outcomes:
measure: AUCt of CKD-330, D085, CKD-333
timeFrame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
measure: Cmax of CKD-330, D085, CKD-333
timeFrame: Pre-dose (0 hour), post-dose 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24, 48, 72 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chungnam National University Hospital
name: Hong Jang Hee, M.D.
role: PRINCIPAL_INVESTIGATOR
References: