Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

Study to Evaluate the Safety and Pharmacokinetics of CKD-349

Study Overview

• Status: Completed
• Conditions: Chronic Heart Failure
• Intervention / Treatment: Drug: D113; Drug: CKD-349

Detailed Description

An Open Label, Randomized, Single-dose, 2-sequence, 2-period, Cross-over Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-349 in Healthy Adult Volunteers

• Study Type: Interventional
• Enrollment (Actual): 71
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gwanak-gu
    • Seoul, Gwanak-gu, Korea, Republic of, 08779
      • H Plus Yangji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years
2. Weight ≥50kg (man) or 45kg (woman), 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 chemistry, serology, urology) and 12-lead ECG results at screening.
5. Those who agree to contraception until 7 days after clinical trial.
6. Individuals 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 have clinically significant diseases or history in digestive systems, cardiovascular system, endocrine system, respiratory system, blood·tumor, infectious disease, kidney and urogenital system, mental·nervous system, musculoskeletal system, immune system, otolaryngology, skin system, ophthalmology system, etc.
2. Those who have a history of gastrointestinal surgery except simple appendectomy and hernia surgery.
3. Those who take barbiturate and any related drugs which may cause induction or inhibition of drug metabolism within 1 month before the first administration of investigational products or take drugs that may interfere with this clinical trials within 10 day before the first administration
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 donated ingredients within 2 weeks, or received a blood transfusion within 4 weeks.
6. Those who exceed an alcohol and cigarette consumption than below criteria A. Alcohol: Man- 21 glasses/week, Woman - 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) B. Smoking: 20 cigarettes/day
7. Those who overreacts to the ingredient of this drug and is administering an angiotensin conversion enzyme (ACE) inhibitor or has not passed 36 hours since discontinuation of administration and has a history of vascular edema when administering an angiotensin conversion enzyme (ACE) inhibitor or an angiotensin receptor antagonist (ARB).
8. Those who are deemed insufficient to participate in this clinical study by investigators.
9. Woman who are pregnant or breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D113/ Period 2: CKD-349	Drug: D113; QD, PO; Drug: CKD-349; QD, PO
Experimental: Sequence2; Period 1: CKD-349/ Period 2: D113	Drug: D113; QD, PO; Drug: CKD-349; QD, PO

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCt of CKD-349	AUCt: Area under the concentration-time curve from time zero to time	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Cmax of CKD-349	Cmax: Maximum plasma concentration of the drug	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCinf of CKD-349	Area under the concentration-time curve from zero up to ∞	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
Tmax of CKD-349	Time to maximum plasma concentration	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
AUCt/AUCinf of CKD-349	AUCt/AUCinf	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours
T1/2 of CKD-349	Terminal elimination half-life	0, 0.08, 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.25, 1.5, 1.75, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: JaeWoo Kim, Study Principal Investigator

Study record dates

Study Major Dates

• Study Start (Actual): November 3, 2021
• Primary Completion (Actual): January 18, 2022
• Study Completion (Actual): April 6, 2022

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 7, 2022
• Last Update Submitted That Met QC Criteria: October 5, 2022
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: A111_01BE2019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No