The Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930

A Single Sequence, 3-period, Multiple-dose Study to Evaluate the Pharmacokinetics of D565 and the Drug Effect of D565 on Pharmacokinetic Characteristics of D930 in Healthy Male Volunteers

This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: D930, D565

Detailed Description

This study is a single sequence, 3-period, multiple-dose study to evaluate the pharmacokinetics of D565 and the drug effect of D565 on pharmacokinetic characteristics of D930 in healthy male volunteers.

Subjects will receive D565 just one time on period 1 for evaluate the pharmacokinetics. And afterward, subjects will receive multiple dose of D930 for 9 days, and D565 with D930 for 9 days to evaluate the drug effect on period 2 and 3.

When period 1 finished, there are 3 days of washout period, but between period 2 and 3, there is no washout period.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan
    • Seo-gu, Busan, Korea, Republic of, 602-715
      • Dong-A University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Healthy male older than 19 years and younger than 55 years at the time of screening
2. BMI 18.0~30.0(kg/m2) and body weight more than 55kg
3. Subject who has no chronic disease within last 3 years, no symptoms or pathological findings
4. Suitable subject who is determined by laboratory tests that hematology test, blood chemistry, urinalysis test according to the characteristics of the drug and 12-lead ECG at the time of screening
5. Subject who fully understand the purpose and content of clinical trials, characteristic of the drug after in-depth explanation, decided to join the clinical trials by their will and signed inform consent
6. Subject who has will and ability to participate in clinical trials

Exclusion Criteria:

1. Subject who has a history of clinically significant blood, kidney, endocrine, respiratory, gastrointestinal, urinary, cardiovascular, liver, psychiatric, neurological, allergic or ophthalmic diseases (except for asymptomatic seasonal allergies not treated at the time of single administration) or who has a following history

1. Patients with liver failure or severe renal disease(CCr < 30ml/min) and cardiovascular patient (CCr is calculated by Cockroft and Gault formula)
2. Patients with acute occlusion angle glaucoma
3. Patients with a history of kidney stones
4. Patients with a history of chronic corneal injury and ophthalmic surgery
5. Patients with decreased endothelial cell count
6. Patients with renal tubular cells immature or with perchloric acidosis
7. Patients receiving MAO inhibitor
8. Patients taking antidepressants that affect noradrenaline delivery
9. Patients with depression, cerebral impairment or coronary artery disease, Raynode phenomenon, standing hypotension, and obstructive thromboangitis
10. Patients with bronchial asthma or history of asthma

2. Those who meet the following criteria on ophthalmological examination or test

1. A person with a history or suspected symptom of visual organs diseases including keratitis, iritis, uveitis, retinitis, dry eye syndrome, and strabismus.
2. Those who have had previous ophthalmic surgery or have undergone ophthalmic laser surgery within 6 months
3. Those whose corrected visual acuity measured at screening is 20/40 (acupuncture visual acuity chart 0.5) or less.
4. Those who have experienced side effects after wearing contact lenses, or who have worn contact lenses since the last month, who can not comply with the prohibition of wearing contact lenses during clinical trials
5. Others who have abnormal findings on ophthalmic examination

3. Patients with a history of gastrointestinal disorders (Crohn's disease, ulcer, acute or chronic pancreatitis, etc.) or gastrointestinal surgery (excluding simple cecal surgery or hernia surgery) that may affect the absorption of pharmaceuticals for clinical trials

4. Clinical laboratory test results showing the following values

1. ALT or AST> 2 times upper limit of normal range
2. eGFR <60 mL / min / 1.73m2 calculated by the Modification of Diet in Renal Disease (MDRD)

5. When the systolic blood pressure is less than 100 mmHg or more than 150 mmHg or diastolic blood pressure is less than 60 mmHg or not less than 100 mmHg

6. Those who have received medication within 3 months prior to the first administration of the clinical trial drug by participating in other clinical trials or bioequivalence studies (However, the ending date of participation in the examination shall be the last day of medication.)

7. Those who have a history of drug abuse within the first year of screening

8. Persons who have been drinking continuously (21 units / week, 1 unit = 10 g of pure alcohol) within 6 months of the first dose or who can not abstain during the trial Example> Beer 5 ° 1 cup (250 ml) = 10 g, Soju 20 ° 1 cup (50 ml) = 8 g, Wine 12 ° 1 cup (125 ml) = 12 g

9. Those taking medication known to induce or inhibit drug metabolizing enzymes within 30 days prior to the first administration of clinical trial medication

10. A person taking any prescribed medicinal product or herbal medicine within 2 weeks of the first day of administration or taking or applying any OTC drug or vitamin preparation including artificial tears within 1 week (However, depending on the testee's judgment, other conditions may be appropriate to participate in the clinical trial)

11. Those who have received a whole blood donation within 2 months before the first administration of the drug for clinical trial, or have received a blood donation and blood transfusion within 1 month

12. Persons with hypersensitivity or clinically significant hypersensitivity reactions to medicinal products for use in clinical trials or drugs containing the same class of ingredients (eg. latanoprost, benzalkonium chloride)

13. Those who are not willing or able to comply with the lifestyle guidelines described in this Protocol,

14. An average of 10 smokers per day over the past three months or who can not quit smoking 48 hours before the first dose

15. Those who are planning to become pregnant during the trial period or who are not planning to use a reliable contraceptive method (Eg, use of contraceptives and transplants or intrauterine devices, infertility procedures (vasectomy, tubal ligation, etc.), blockage (condoms and spermicide), vaginal septa, vaginal sponges,

16. A person who is found to be unsuitable for clinical trial participation due to other reasons including clinical laboratory test results

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A single sequence, 3-period	Drug: D930, D565; Period 1: D565 administered 1 time for one day/ Period 2: D930 administered 3 time per day for 9 days/ Period 3: D565(1 time per day) with D930(3 time per day) administered for 9days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AUCtau,ss of D930	predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Cmax,ss of D930	predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

Secondary Outcome Measures

Outcome Measure	Time Frame
AUCt of D565	predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Cmax of D565	predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Tmax of D565	predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
t1/2 of D565	predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
AUCinf of D565	predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h
Ctrough, ss of D930	predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
Tmax,ss of D930	predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
t1/2 of D930	predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h
AUCinf of D930	predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Min Kyu Park, Ph.D, The Dong-A University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 17, 2017
• Primary Completion (ACTUAL): March 17, 2017
• Study Completion (ACTUAL): March 20, 2017

Study Registration Dates

• First Submitted: January 25, 2017
• First Submitted That Met QC Criteria: January 26, 2017
• First Posted (ESTIMATE): January 27, 2017

Study Record Updates

• Last Update Posted (ACTUAL): July 31, 2017
• Last Update Submitted That Met QC Criteria: July 28, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Glaucoma
• Other Study ID Numbers: 171DDI16019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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