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

NCT05207761 | Completed Phase 1

• 1 other identifier: A71_05DDI2114
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (2)

Sequence 1

EXPERIMENTAL

1. Period 1: D565 7days 2. Period 2: D565+D930 91days

Drug: D565; Drug: D930

Sequence 2

EXPERIMENTAL

1. Period 1: D930 91days 2. Period 2: D565+D930 7days

Drug: D565; Drug: D930

Interventions

D565 DRUG

Q.D. in both eye

Sequence 1; Sequence 2

D930 DRUG

T.I.D in both eye

Sequence 1; Sequence 2

Eligibility Criteria

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

You may qualify if:

• Healthy adults volunteers aged between 19 and 55 years old at the time of screening
• Weight ≥ 55 kg, Calculated Body Mass Index(BMI) of 18.0 to 30.0 kg/m2
• \* BMI = Weight(kg)/ Height(m)2
• Individuals who sign an informed consent form and decide to participate in the study after being fully informed of the study prior to participation
• 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

You may not qualify if:

• 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
• 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
• 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
• Individuals with sitting systolic blood pressure ≥ 140 mmHg or ≤ 80 mmHg or sitting diastolic blood pressure ≥ 90 mmHg or ≤ 45 mmHg
• 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
• Individuals who continue to drink(over 21 units/week) within 1 month or cannot abstain from alcohol during the clinical trial period

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

Seoul National University College of Medicine and Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

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

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: January 26, 2022
• Study Start: January 19, 2022
• Primary Completion: October 18, 2022
• Study Completion: November 2, 2022
• Last Updated: January 5, 2023

Record last verified: 2023-01

Locations

KR (1)