Clinical trial NCT06758661: Clinical Study to Evaluate Drug-drug Interaction and Safety After Co-administration of D352 and D794 in Healthy Adult Volunteers
Official title: An Open-label, Single-arm, Crossover, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction and Safety After the Co-administration of D352 and D794, in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dyslipidemia
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2025-01-06
Enrollment: 40
Sex: ALL
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

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

Primary outcomes:
measure: AUCtau,ss of D352(Part 1)
timeFrame: 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
measure: AUCtau,ss of D794(Part 2)
timeFrame: 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
measure: Cmax,ss of D352(Part 1)
timeFrame: 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
measure: Cmax,ss of D794(Part 2)
timeFrame: 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
Secondary outcomes:
Other outcomes:
Locations:
city: Gwanak-gu
country: Korea, Republic of
facility: H Plus Yangji Hospital
state: Seoul
Study officials:
References: