Clinical trial NCT04260438: Clinical Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
Official title: An Open-label, Randomized, Fed, Single Dose, Crossover Study to Evaluate the Pharmacokinetics, Safety and Tolerability of CKD-393 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-02-07
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is an open-label, randomized, fed, single dose, crossover study to evaluate the pharmacokinetics, safety and tolerability of CKD-393 in healthy subjects

Detailed description: To healthy subjects of twenty-four (24), following treatments are administered dosing in each period and wash-out period is a minimum of 7 days.

Reference drug: 1) CKD-501 0.5mg 2) D759 3) D150 Test drug: 1) CKD-393 0.5/100/1000mg formulation Ⅰ Tab. 2) CKD-393 0.5/100/1000mg formulation Ⅱ Tab.

Pharmacokinetic blood samples are collected up to 48hrs. The pharmacokinetic characteristics and safety are assessed.

Eligibility criteria: Inclusion Criteria:

1. Healthy male volunteers, aged between ≥ 19 and ≤ 55 years old at the time of screening.
2. Weight ≥ 50kg, with calculated body mass index (BMI) of ≥ 18.5 and ≤ 29.9 kg/m2

   \* BMI = Weight(kg)/ Height(m)2
3. Subject who consents to use at least two clinically effective birth controls for at least 1 month following the last dose.
4. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written.

Exclusion Criteria:

1. History or presence of clinically significant and sever active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder.
2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product (IP) administration.
3. Any medical history that may affect drug absorption, distribution, metabolism and excretion.
4. Individuals who had history of hypersensitivity to follow drugs, derivative drugs or others drugs(aspirin and antibiotics etc.) or had history of drug abuse

   * Thiazolidinedione
   * DPP-4 inhibitor
   * Metformin
5. Any clinically significant chronic medical illness.
6. Any genetic disease including galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption.
7. Individuals with one of the following laboratory test results in screening

   * AST, ALT \> UNL (upper normal limit) x 3
   * fasting glucose \< 70 mg/dL or \> 125 mg/dL
   * Creatinine clearance ≤ 80 mL/min
   * In ECG result, QTc \> 450 msec
   * hCG(+) (only women)
8. Individuals who had positive test results at HBs Ag, anti-HCV Ab, anti-HIV Ab, VDRL.
9. Use of any prescription drugs within 14 days prior to study drug administration.
10. Use of over-the-counter medications and herbal preparations within 7 days prior to study drug administration.
11. History of any clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not required medication may be allowed).
12. Individuals who cannot eat standard meal provided from clinical trial center.
13. Donation of blood within 60 days prior to study drug administration or apheresis within 20 days prior to the first IP administration.
14. Individuals who had received a blood transfusion within 30 days prior to study drug administration.
15. Exposure to any investigational drug within 6 months prior to the first IP administration.
16. Individuals taking any drugs inducing or inhibiting drug metabolizing enzymes including barbiturates within 30 days prior to the first IP administration.
17. Individuals who had consumed grapefruit juice \> 5cups/day or caffeine \> 5cups/day within 30 days prior to the first IP administration or who cannot stopping consume grapefruit juice or caffeine during clinical study.
18. Individuals who had drinking (alcohol \> 30 g/day) within 30 days prior to the first IP administration or who cannot stopping drink.
19. Heavy smoking (more than 10 cigarettes/day) within 30 days prior to screening or who cannot quit smoking during clinical study.
20. Pregnant or women who may be pregnant
21. Subjects having been deemed inappropriate for the trial as determined by the investigator.

Primary outcomes:
measure: AUCt of CKD-501, D759, D150, CKD-393
timeFrame: Time Frame: 0 hour ~ 48 hours
measure: Cmax of CKD-501, D759, D150, CKD-393
timeFrame: Time Frame: 0 hour ~ 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
References: