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

NCT06758661 | Completed Phase 1

• 1 other identifier: A149_01DDI2409
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Dyslipidemia

Outcome Measures

Primary Outcomes (4)

• AUCtau,ss of D352(Part 1)

  Area under the D352 concentration in blood-time curve in steady-state

  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

• AUCtau,ss of D794(Part 2)

  Area under the D794 concentration in blood-time curve in steady-state

  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

• Cmax,ss of D352(Part 1)

  The maximum D352 concentration in steady-state

  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

• Cmax,ss of D794(Part 2)

  The maximum D794 concentration in steady-state

  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

Study Arms (2)

D352-D352+D794(Part 1)

EXPERIMENTAL

Period 1: D352 1 tablet for 1 week, Period 2: D352 1 tablet and D794 4 capsule for 2 weeks

Drug: D352; Drug: D794

D794-D352+D794(Part 2)

EXPERIMENTAL

Period 1: D794 4 capsule for 2 weeks, Period 2: D352 1 tablet and D794 4 capsule for 1 week

Drug: D352; Drug: D794

Interventions

D352 DRUG

1 tablet

D352-D352+D794(Part 1); D794-D352+D794(Part 2)

D794 DRUG

4 capsule

D352-D352+D794(Part 1); D794-D352+D794(Part 2)

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult volunteers between the ages of 19 years to 55 years.
• 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
• Individuals without congenital/chronic diseases and without abnormal symptoms or diagnosis based on a medical examination
• Individuals who were deemed to be appropriate as study subjects following vital sign, laboratory tests (hematology, blood chemistry, serology, urology etc.) etc. performed
• 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
• Individuals who signed an informed consent form after being fully informed of the study prior to participation, including the objective, content, adverse events etc.

You may not qualify if:

• Individuals with a history of hypersensitivity to any of the major ingredients or components of the investigational product
• Individuals who have genetic problems such as galactose intolerance, Lap lactase deficiency, or glucose-galactose malabsorption
• Individuals who have a history of hypersensitivity or allergy to this ingredient because it contains Sunset Yellow FCF
• 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
• Individuals with a history of gastrointestinal surgery or gastrointestinal disease that may affect drug absorption
• 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
• 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
• Individuals who have used drugs that induce or inhibit drug metabolizing enzymes, such as barbiturates, within 1 month before the first dosing administration
• 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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

H Plus Yangji Hospital

Gwanak-gu, Seoul, 08779, South Korea

Location

MeSH Terms

Conditions

Dyslipidemias

Interventions

1-stearoyl-d35-2-docosahexaenoyl-sn-glycero-3-phosphocholine

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 6, 2025
• Study Start: November 27, 2024
• Primary Completion: January 24, 2025
• Study Completion: February 3, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

KR (1)