Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers

• Sponsor: Chong Kun Dang Pharmaceutical (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05335044
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 2.1
• Patients Per Site Per Month: 20.3

Study Details

Study Description

Brief Summary

Phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Condition or Disease	Intervention/Treatment	Phase
Hypertension and Dyslipidemia	Drug: CKD-331; Drug: EX5619	Phase 1

Detailed Description

An open-label, randomized, single-dose, 2-sequence, 4-period, cross-over, phase 1 study to evaluate the safety and pharmacokinetics of CKD-331 in healthy adult volunteers

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label, Randomized, Single-dose, 2-sequence, 4-period, Cross-over, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of CKD-331 in Healthy Adult Volunteers
• Anticipated Study Start Date: Apr 29, 2022
• Anticipated Primary Completion Date: Jun 25, 2022
• Anticipated Study Completion Date: Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sequence A Period 1: EX5619 - A single oral dose of 1 tablet under fasting condition Period 2: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 3: EX5619 - A single oral dose of 1 tablet under fasting condition Period 4: CKD-331 - A single oral dose of 2 tablets under fasting condition	Drug: CKD-331; QD, PO; Drug: EX5619; QD, PO
Experimental: Sequence B Period 1: CKD-331 - A single oral dose of 2 tablets under fasting condition Period 2: EX5619 - A single oral dose of 1 tablet under fasting condition Period 3: CKD-331 - A single oral dose of 2 tablets under fasting condition Peirod 4: EX5619 - A single oral dose of 1 tablet under fasting condition	Drug: CKD-331; QD, PO; Drug: EX5619; QD, PO

Outcome Measures

Primary Outcome Measures

1. Cmax of CKD-331 [Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours]

   Cmax: Maximum plasma concentration of the drug

2. AUCt of CKD-331 [Pre-dose (0 hour), 0.17, 0.33, 0.5, 0.67, 0.83, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 34 hours]

   AUCt: Area under the concentration-time curve from time zero to time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19 years

2. Weight ≥55kg 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 during the participation of 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 no medical history of disgetive disease, cardiovasular disease, endocrine disease, respiratory system, blood·tumor disease, infection disease, nephrology disease, genitourinary disease, neuron disease, skeletal disease, imunological disease, otolaryngological disease, dermatological disease, ophatological disease

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.

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 or apheresis within 8 weeks or 4 weeks respectfully, or received blood transfusion within a month.

6. Those who exceed an alcohol and cigarette consumption than below criteria Alcohol

• Man: 21 glasses/week

• Woman: 14 glasses/week (1 glass: Soju 50mL, Wine 30mL, or beer 250mL) Smoking: 20 cigarettes/day

1. Those who have genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption.

2. Those who are deemed insufficient to participate in this clinical study by investigators.

3. Woman who are pregnant or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	H plus Yangji hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Chong Kun Dang Pharmaceutical

Investigators

• Principal Investigator: Jaewoo Kim, M.D., PhD., Yanhji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chong Kun Dang Pharmaceutical
• ClinicalTrials.gov Identifier: NCT05335044
• Other Study ID Numbers: A124_01BE2203
• First Posted: Apr 19, 2022
• Last Update Posted: Apr 19, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dyslipidemias

Study Results

No Results Posted as of Apr 19, 2022