Clinical Study to Investigate the PK Profiles and Safety of CKD-385 in Healthy Volunteers Under Fasting Conditions

A Randomized, Open-label, Single Dose, Crossover Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers Under Fasting Conditions

Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers under Fasting Conditions

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Drug: Reference drug; Drug: Test drug 1; Drug: Test drug 2

Detailed Description

A randomized, open-label, single dose, crossover study to investigate the pharmacokinetic profiles and safety of high-dose CKD-385 in healthy volunteers under fasting conditions

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Siheung-si
    • Gyeonggi-do, Siheung-si, Korea, Republic of, 15079
      • Central Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult aged more than 19 at the time of screening

2. Those who had 18.0kg/m² ≤ Body Mass Index (BMI) < 30.0kg/m²

   # BMI=Weight(kg) / Height(m)²

3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings on a medical examination.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, urinalysis, serology), vital signs and ECG results at screening.
5. Those who have voluntarily given written informed consents to participate in the study and to comply with all the instructions, based on full understanding of the nature of the study after listening to detailed explanations.
6. Those who agree to double contraception method from the 1st administration of the investigational product until 7 days after the last administration of investigational product.

Exclusion Criteria:

1. Those who has medical evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, urinary, cardiovascular, hepatic, psychiatric, neurologic or allergic diseases(except for simple dental history such as tartar, impacted teeth, wisdom teeth).
2. Those with a medical history of gastrointestinal disorders(esophageal achalasia or esophagus stenosis, Crohn's disease) or gastrointestinal surgery(except for simple appendicitis surgery or hernia surgery or tooth extraction surgery) that may affect the absorption of drug.
3. Those who has a history of regular alcohol consumption in excess of 14 glasses/week for woman, 21 glasses/week for man within 1 months prior to screening.
4. Those who received investigational products or bioequivalence test drugs within 6 months before the first administration of clinical trial drugs.
5. Those who take drugs which may cause induction or inhibition of drug metabolism within 30 days before the first administration of investigational products.
6. Those who have taken any drugs that may affect the clinical trial within 10 days.
7. Those who donated whole blood within 2 months, or blood components within 2 week before first administration of investigational products.
8. Those who are deemed insufficient to participate in this clinical study by investigators.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group 1; Period 1: Reference drug; Period 2: Test drug 1; Period 3: Test drug 2	Drug: Reference drug; 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug 1; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg); Drug: Test drug 2; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 2; Period 1: Test drug 2; Period 2: Reference drug; Period 3: Test drug 1	Drug: Reference drug; 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug 1; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg); Drug: Test drug 2; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 3; Period 1: Test drug 1; Period 2: Test drug 2; Period 3: Reference drug	Drug: Reference drug; 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug 1; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg); Drug: Test drug 2; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 4; Period 1: Test drug 2; Period 2: Test drug 1; Period 3: Reference drug	Drug: Reference drug; 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug 1; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg); Drug: Test drug 2; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 5; Period 1: Test drug 1; Period 2: Reference drug; Period 3: Test drug 2	Drug: Reference drug; 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug 1; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg); Drug: Test drug 2; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg)
EXPERIMENTAL: Group 6; Period 1: Reference drug; Period 2: Test drug 2; Period 3: Test drug 1	Drug: Reference drug; 1 Cap., single oral administration under fasting condition; Other Names: D744; Drug: Test drug 1; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg); Drug: Test drug 2; 1 Tab., single oral administration under fasting condition; Other Names: CKD-385 64 mg formulation I (878mg)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-385	Area under the concentration-time curve from time zero to time of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-385	Maximum plasma concentration of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of CKD-385	Area under the concentration-time curve from zero up to infinity of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Tmax of CKD-385	Time to maximum plasma concentration of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
T1/2 of CKD-385	Terminal elimination half-life of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
CL/F of CKD-385	Apparent clearance of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours
Vd/F of CKD-385	Apparent Volume of Distribution of CKD-385	Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12, 24, 48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min-gi Kim, Central Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2020
• Primary Completion (ANTICIPATED): December 12, 2020
• Study Completion (ANTICIPATED): December 12, 2020

Study Registration Dates

• First Submitted: November 26, 2020
• First Submitted That Met QC Criteria: December 17, 2020
• First Posted (ACTUAL): December 21, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 21, 2020
• Last Update Submitted That Met QC Criteria: December 17, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: A88_08BE2015P

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No