A Clinical Study to Evaluate the Safety and Pharmacokinetics of CKD-344

An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-344 in Healthy Adult Volunteers

A Clinical Trial to evaluate the Pharmacokinetics and safety of CKD-344

Study Overview

• Status: Unknown
• Conditions: Anticoagulant
• Intervention / Treatment: Drug: Lixiana(D006); Drug: CKD-344

Detailed Description

A Phase 1 Clinical Trial to evaluate the safety and pharmacokinetics in healthy adult volunteers after administration of CKD-344.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Yook-Hwan Noh, M.D., PhD.

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yook-Hwan Noh
    • Contact: Yook-Hwan Noh; Phone Number: +827046659174; Email: yook.noh@gmail.com

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 volunteers aged ≥ 19 years
2. Weight ≥60kg, with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who have no congenital diseases or chronic diseases and have no abnormal symptoms or findings.
4. Those who are eligible for clinical trials based on laboratory (hematology, blood coagulation, blood chemistry, serology, urinalysis) at screening.
5. Those who agree to contraception during the participation of clinical trial.
6. Those who voluntarily decide to participate and agree to comply with the cautions after fully understand the detailed description of this clinical trial.

Exclusion Criteria:

1. Those who has a medical evidence or a history of clinically significant gastrointestinal, cardiovascular, endocrine, pulmonary, hematological, infective disease, renal, urinary, psychiatric, neurologic, skeleto-muscular, immune, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who had taken prescription or nonprescription drugs within 10 days prior to the first dose of investigational product.
4. Those who received investigational products or participated in bioequivalence tests within 6 months before the first administration of clinical trial drugs.
5. Those who donated whole blood within 2 months or blood components within 1 month prior to the first dose of the investigational product.
6. Those who exceed an alcohol and cigarette consumption than below criteria. A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week B. Smoking: 20 cigarettes/day
7. Those who exceeds 2 times the upper limit of the reference range of AST(or ALT) or 1.5 times the upper limit of the reference range of γ-GTP.
8. Those who have hypersensitivity to the drug or the drug ingredient, such as anaphylactic reactions.
9. Those who have specific disease(e.g. severe bleeding disorder, severe renal/hepatic disease, uncontrolled severe hypertension, etc.)
10. Those who were deemed inappropriate to participate in the study by the investigator.
11. Those who have a pregnant or nursing woman.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Group A; Period 1: Reference drug(Lixiana 60 mg); Period 2: Test drug(CKD-344 60 mg)	Drug: Lixiana(D006); NOAC(Factor Xa inhibitor); Other Names: Reference Drug; Drug: CKD-344; NOAC(Factor Xa inhibitor); Other Names: Test Drug
EXPERIMENTAL: Group B; Period 1: Test drug(CKD-344 60 mg); Period 2: Reference drug(Lixiana 60 mg)	Drug: Lixiana(D006); NOAC(Factor Xa inhibitor); Other Names: Reference Drug; Drug: CKD-344; NOAC(Factor Xa inhibitor); Other Names: Test Drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt(Area Under Curve last) of CKD-344	Area under the plasma concentration time curve of CKD-344, from time zero up to the last measurable concentration.	predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose
Cmax	The maximum concentration observed of CKD-344 over blood sampling time.	predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 hours post-dose

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Study Director: Yook-Hwan Noh, H plus Yangji Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 13, 2020
• Primary Completion (ANTICIPATED): December 26, 2020
• Study Completion (ANTICIPATED): January 2, 2021

Study Registration Dates

• First Submitted: November 8, 2020
• First Submitted That Met QC Criteria: December 16, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2020
• Last Update Submitted That Met QC Criteria: December 16, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: A109_01BE2017

Drug and device information, study documents

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