Clinical trial NCT02916901: Study to Investigate the Influence of CKD-519 on 24-h Ambulatory Blood Pressure in Healthy Adult Volunteers
Official title: A Randomized, Double-blind, Placebo-controlled, Multiple Dosing, Cross-over Phase I Clinical Trial to Investigate the Effect of CKD-519 on 24-h Ambulatory Blood Pressure After Oral Administration in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Dyslipidemia
CKD-519
CETP inhibitor
ABPM
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2016-09-28
Enrollment: 32
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine influence of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.

Detailed description: A randomized, double-blind, placebo-controlled, multiple dosing, cross-over phase I clinical trial to investigate the effect of CKD-519 on 24-h ambulatory blood pressure after oral administration in healthy adult volunteers.

Eligibility criteria: Inclusion Criteria:

1. Between 19 aged and 55 aged in healthy adult
2. Body weight more than 55kg in male, 50kg in female
3. Body Mass Index more than 18.5 and under 25(body mass index=kg/m2)
4. 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
5. 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
6. 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.

Exclusion Criteria:

1. Have clinically significant disease that hepatobiliary system(severe hepatic impairment, etc), kidney(severe renal impairment, etc), nervous system, immune system, respiratory system, endocrine system, hemato-oncology disease, cardiovascular system(heart failure, etc) or mental illness, or a history of mental disease.
2. Have a gastrointestinal disease history that can effect drug absorption(Crohn's disease, ulcers, etc.) or surgery(except simple appendectomy or hernia surgery)
3. Hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of drugs or additives.
4. 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.
5. Defined by the following laboratory parameters

   * AST, ALT\>1.25 upper limit of normal range
   * Total bilirubin\>1.5 upper limit of normal range
   * CPK\>1.5 upper limit of normal range
   * eGFR(using by MDRD method)\<60mL/min/1.73m2
6. Sitting SBP \> 140mmHg or \< 90mmHg, sitting DBP \> 90mmHg or \< 60mmHg, after 5 minutes break.
7. The difference in DBP\>10mmHg or SBP \>20mmHg at the screening period
8. Drug abuse or have a history of drug abuse shows a positive for urine drug test.
9. Pregnant or lactating women.
10. A heavy caffeine consumer(caffeine\>5 cups/day), alcohol consumer(alcohol\>210g/week),
11. smoker(except the one who have stopped smoking more than 90days before beginning of study treatment)
12. Subject takes ethical drug or herbal medicine within 14 days, OTC 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.
13. Subject who takes inhibitor and inducers of drug metabolizing enzyme(Barbiturates etc.) within 30 days.
14. Taking foods containing grapefruit within 7 days before the beginning of study treatment(ex. Drinking containing grapefruit of 1L per a day or more within 7 days before the beginning of study treatment)
15. Subject who treated with any investigational drugs within 90 days before the beginning of study treatment
16. Previously donate whole blood within 60 days or component blood within 30 days.
17. Positive for Serology test(Hepatitis B, Hepatitis C, HIV)
18. An impossible one who participants in clinical trial by investigator's decision including laboratory test result or another reason

Primary outcomes:
measure: Change in 24h average SBP and DBP from baseline to Day 14 Each time point is as following: Daytime: 06:00~21:59 Nighttime: 22:00~05:59
timeFrame: 14days
Secondary outcomes:
measure: Cmax,ss of CKD-519
timeFrame: 0(predose)~24 at day15
measure: AUCτ,ss of CKD-519
timeFrame: 0(predose)~24 at day15
measure: Tmax,ss of CKD-519
timeFrame: 0(predose)~24 at day15
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
state: Seodaemun-gu 120-752
Study officials:
affiliation: Severance Hospital
name: Min Soo Park, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: