Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930

A Randomized, Open-label, 2-period, Parallel Group, Multiple-dose Phase 1 Study to Evaluate Drug-drug Interaction, Safety and Tolerability in Case of the Co-administration of D565 and D930, in Healthy Male Subjects

This study is a randomized, open-label, 2-period, parallel group, multiple-dose phase 1 study to evaluate drug-drug Interaction, safety and tolerability in case of the co-administration of D565 and D930, in healthy male subjects

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Drug: D565; Drug: D930

Detailed Description

To healthy male subjects of thirty-two (32), Investigational products are administered following treatments in each period

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University College of Medicine and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy adults volunteers aged between 19 and 55 years old at the time of screening

2. Weight ≥ 55 kg, Calculated Body Mass Index(BMI) of 18.0 to 30.0 kg/m2

   * BMI = Weight(kg)/ Height(m)2

3. Individuals who sign an informed consent form and decide to participate in the study after being fully informed of the study prior to participation
4. Individuals who are suitable as a subject for this study at the discretion of the researcher as a result of screening tests such as examination, laboratory tests and questionnaires

Exclusion Criteria:

1. Individuals who have other clinically significant cardiovascular system, respiratory system, liver, renal, nervous system, endocrine system, blood-oncology, psychiatric disorders, urinary system or ophthalmic diseases or have a history

2. Individuals who satisfy the following items during the interview or examination

   • Individuals with a history of or sign or symptoms of a disease of the visual system
   • Individuals who had an ophthalmic surgery including for refractive correction surgery such as LASIK.
   • Individuals with corrected visual acuity of 20/40 or less
   • Individuals who have experienced side effects after wearing contact lenses or who have worn contact lenses within the last month
   • Individuals who have more than 21mmHg or less than 10mmHg on either side of the intraocular pressure test
   • Individuals who show abnormal findings in other ophthalmic examinations
3. Individuals who have a history of hypersensitivity to the active ingredient and component of the investigational drug, or to the drug in the same class as the active ingredient
4. Individuals with sitting systolic blood pressure ≥ 140 mmHg or ≤ 80 mmHg or sitting diastolic blood pressure ≥ 90 mmHg or ≤ 45 mmHg

5. Individuals with the following results at screening test

   • AST, ALT, γ-GT > 2x the upper limit of the normal range
   • Total bilirubin > 2.0 mg/dL
   • eGFR(CKD-EPI) < 60 mL/min/1.73m2
6. Individuals who continue to drink(over 21 units/week) within 1 month or cannot abstain from alcohol during the clinical trial period
7. Individuals who tested positive in an alcohol breath analysis
8. Individuals who continuously smoke within one month(including e-cigarettes, over 10 fees/day) or who cannot quit smoking during the clinical trial period;
9. Individuals who cannot restrict the intake of grapefruit or grapefruit-containing food from 3 days before administration of investigational drugs to the final pharmacokinetic blood sample collection
10. Individuals who tested positive for urine cotinine at screening test
11. Individuals who took ethical(ETC) or oriental medicine within 2 weeks or over the counter(OTC) within 1 week before the expected first dose
12. Individuals taking medication known to significantly induce or inhibit drug metabolizing enzymes within 1 month before the expected first dose
13. Individuals with a medical history of significant drug abuse or positive for abuse drug in urine test results at screening
14. Individuals who had been administered investigational product(s) of other clinical study within the 6 months prior to the first dose of this study
15. Individuals who donated whole blood within the 2 months, or donated blood components within 1 month, or received a blood transfusion with 1month prior to the first dose or plan to donate blood or transfusion during the clinical trial period
16. Individuals who are unable to use an appropriate medically approved method of contraception for themselves, their spouses, or partners during the entire clinical trial period and for at least 90 days after the last investigational drug administration and cannot donate sperm during this period
17. Individuals who were deemed to be inappropriate to participate in the study by the investigator

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Period 1: D565 7days; Period 2: D565+D930 91days	Drug: D565; Q.D. in both eye; Drug: D930; T.I.D in both eye
Experimental: Sequence 2; Period 1: D930 91days; Period 2: D565+D930 7days	Drug: D565; Q.D. in both eye; Drug: D930; T.I.D in both eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCtau,ss of D565(Sequence1)	Area under the D565 concentration in blood-time curve from 0 to τ at steady state	1day 0hour ~ 99day 0hour
AUCtau,ss of D930(Sequence1)	Area under the D930 concentration in blood-time curve from 0 to τ at steady	8day 0hour ~ 99day 0hour
AUCtau,ss of D565(Sequence2)	Area under the D565 concentration in blood-time curve from 0 to τ at steady state	96day 0hour ~ 99day 0hour
AUCtau,ss of D930(Sequence2)	Area under the D930 concentration in blood-time curve from 0 to τ at steady	1day 0hour ~ 99day 0hour
Cmax,ss of D565(Sequence1)	The maximum D565 concentration between 0 and τ at steady state	1day 0hour ~ 99day 0hour
Cmax,ss of D930(Sequence1)	The maximum D930 concentration between 0 and τ at steady state	8day 0hour ~ 99day 0hour
Cmax,ss of D565(Sequence2)	The maximum D565 concentration between 0 and τ at steady state	96day 0hour ~ 99day 0hour
Cmax,ss of D930(Sequence2)	The maximum D930 concentration between 0 and τ at steady state	1day 0hour ~ 99day 0hour

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): October 18, 2022
• Study Completion (Actual): November 2, 2022

Study Registration Dates

• First Submitted: January 4, 2022
• First Submitted That Met QC Criteria: January 24, 2022
• First Posted (Actual): January 26, 2022

Study Record Updates

• Last Update Posted (Actual): January 5, 2023
• Last Update Submitted That Met QC Criteria: January 3, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: A71_05DDI2114

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No