Clinical Study to Evaluate Drug-drug Interaction and Safety After Co-administration of D352 and D794 in Healthy Adult Volunteers

Phase 1

Active, not recruiting

• Conditions: Dyslipidemia
• Interventions: Drug: D352; Drug: D794

• Registration Number: NCT06758661
• Lead Sponsor: Chong Kun Dang Pharmaceutical

Brief Summary

This study is a randomized, open-label, single arm, multi-dose, crossover study to evaluate drug-drug interaction and safety after co-administration of D352 and D794 in healthy adult volunteers.

Detailed Description

36 healthy subjects are administration of D352 and D794 following each part. Pharmacokinetic blood samples are collected 1d to 22d. The drug-drug interaction and safety are assessed.

Study Timeline

• Study Start: 2024-11-27
• Status Verified: 2024-12
• Study First Submitted: 2024-12-26
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-06
• Last Update Posted: 2025-01-06
• Primary Completion: 2025-01-24
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Healthy adult volunteers between the ages of 19 years to 55 years.
2. Individuals who had 18 kg/m2 ≤ Body Mass Index(BMI) < 30 kg/m2 and total body weight ≥ 55 kg (woman total body weight ≥ 45 kg) BMI = Weight(kg)/ Height(m)2
3. Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
4. Individuals who were deemed to be appropriate as study subjects following vital sign, laboratory tests (hematology, blood chemistry, serology, urology etc.) etc. performed
5. Individuals who agreed proper contraception during the study and did consent to not donation of sperm or eggs 14 days after the last dose of study drug
6. Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective, content, adverse events etc.

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Exclusion Criteria

1. Individuals with a history of hypersensitivity to any of the major ingredients or components of the investigational product

2. Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption

3. Individuals who have a history of hypersensitivity or allergy to this ingredient because it contains Sunset Yellow FCF

4. Patients with the following diseases

   • Patients with active liver disease or persistently elevated aminotransferase levels of unknown cause
   • Patients with severe hepatic impairment of biliary obstruction and patients with cholestasis
   • Patients receiving cyclosporine
   • Myopathic patients

5. Individuals with a history of gastrointestinal surgery or gastrointestinal disease that may affect drug absorption

6. Individuals who exceed the following condition with 1 month of the first administration of investigational product

   • Alcohol: Man-21 glasses/week, Woman-14 glasses/week (1 glass = soju 50mL or liquor 30mL or beer 250mL)
   • Smoking: 20 cigarettes/day

7. Individuals who cannot restrict the intake of grapefruit or food containing grapefruit from three days before the first administration of investigational product until the final pharmacokinetic blood sample is collected

8. Individuals who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing administration

9. Individuals who have taken any specialty or herbal medicine within 2 weeks prior to the first administration, or any over-the-counter(OTC) or dietary supplement or vitamin preparation, including liver function supplements, within 1 week prior to the first administration

10. Individuals with a history of substance abuse or test positive for drugs of abuse on a urine screening test

11. Individuals who had been administered investigational product from other clinical study within the 6 months prior to the first administration

12. Individuals who donated whole blood within the 8 weeks, or blood components within 2 weeks or had a blood transfusion within 4 weeks prior to the first administration of investigational product

13. Woman who are pregnant or breastfeeding

14. Individuals who have difficulty abstaining from omega-3-containing foods(such as oily fish, chia seeds, flaxseeds, walnuts, etc.) from 7 days before the first administration until the end of study

15. Individuals who determines that the tester is unfit to participate in the clinical trial in the final inclusion/exclusion criteria determined by combining the results of the clinical laboratory test conducted on the hospitalization date(-7D)

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
D352-D352+D794(Part 1)	D352	Period 1: D352 1 tablet for 1 week, Period 2: D352 1 tablet and D794 4 capsule for 2 weeks
D352-D352+D794(Part 1)	D794	Period 1: D352 1 tablet for 1 week, Period 2: D352 1 tablet and D794 4 capsule for 2 weeks
D794-D352+D794(Part 2)	D352	Period 1: D794 4 capsule for 2 weeks, Period 2: D352 1 tablet and D794 4 capsule for 1 week
D794-D352+D794(Part 2)	D794	Period 1: D794 4 capsule for 2 weeks, Period 2: D352 1 tablet and D794 4 capsule for 1 week

Primary Outcome Measures

Name	Time	Method
Cmax,ss of D352(Part 1)	1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour	The maximum D352 concentration in steady-state
Cmax,ss of D794(Part 2)	1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour	The maximum D794 concentration in steady-state
AUCtau,ss of D352(Part 1)	1~7day 0 hour, 7day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24 hour	Area under the D352 concentration in blood-time curve in steady-state
AUCtau,ss of D794(Part 2)	1day -24 hour~-12 hour, 1~14day 0 hour, 14day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour, 19~21day 0 hour, 21day 1, 2, 3, 4, 5, 6, 7, 8, 10, 12, 24 hour	Area under the D794 concentration in blood-time curve in steady-state

Trial Locations

Locations (1)

H Plus Yangji Hospital; 🇰🇷 Gwanak-gu, Seoul, Korea, Republic of