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

Anticoagulant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04867200
• Other study ID #: A109_02BE2106
• Status: Recruiting
• Phase: Phase 1
• Start date: April 27, 2021
• Est. completion date: June 1, 2021

Study information

• Verified date: April 2021
• Source: Chong Kun Dang Pharmaceutical
• Contact: Yook-Hwan Noh, M.D., PhD.
• Phone: +82-70-4665-9174
• Email: yook.noh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2021
• Est. primary completion date: May 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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, skeletomuscular, 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 8 weeks or blood components within 4 weeks 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 ?-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.

Related Conditions & MeSH terms

• Anticoagulant

Intervention

Drug:
• Lixiana(D006)
NOAC(Factor Xa inhibitor)
• CKD-344
NOAC(Factor Xa inhibitor)

Locations

Country	Name	City	State
Korea, Republic of	H+ Yangji Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Chong Kun Dang Pharmaceutical

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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