NCT03034486

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Feb 2017

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 27, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

February 17, 2017

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2017

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2017

Completed
Last Updated

July 31, 2017

Status Verified

July 1, 2017

Enrollment Period

28 days

First QC Date

January 25, 2017

Last Update Submit

July 28, 2017

Conditions

Healthy

Keywords

Glaucoma

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (9)

  • 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

  • +4 more secondary outcomes

Study Arms (1)

A single sequence, 3-period

EXPERIMENTAL
Drug: D930, D565

Interventions

D930, D565DRUG

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

A single sequence, 3-period

Eligibility Criteria

Age19 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male older than 19 years and younger than 55 years at the time of screening
  • BMI 18.0\~30.0(kg/m2) and body weight more than 55kg
  • Subject who has no chronic disease within last 3 years, no symptoms or pathological findings
  • 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
  • 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
  • Subject who has will and ability to participate in clinical trials

You may not qualify if:

  • \. 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
  • Patients with liver failure or severe renal disease(CCr \< 30ml/min) and cardiovascular patient (CCr is calculated by Cockroft and Gault formula)
  • Patients with acute occlusion angle glaucoma
  • Patients with a history of kidney stones
  • Patients with a history of chronic corneal injury and ophthalmic surgery
  • Patients with decreased endothelial cell count
  • Patients with renal tubular cells immature or with perchloric acidosis
  • Patients receiving MAO inhibitor
  • Patients taking antidepressants that affect noradrenaline delivery
  • Patients with depression, cerebral impairment or coronary artery disease, Raynode phenomenon, standing hypotension, and obstructive thromboangitis
  • Patients with bronchial asthma or history of asthma
  • \. Those who meet the following criteria on ophthalmological examination or test
  • A person with a history or suspected symptom of visual organs diseases including keratitis, iritis, uveitis, retinitis, dry eye syndrome, and strabismus.
  • Those who have had previous ophthalmic surgery or have undergone ophthalmic laser surgery within 6 months
  • Those whose corrected visual acuity measured at screening is 20/40 (acupuncture visual acuity chart 0.5) or less.
  • +18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dong-A University Hospital

Seo-gu, Busan, 602-715, South Korea

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Min Kyu Park, Ph.D

    The Dong-A University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 25, 2017

First Posted

January 27, 2017

Study Start

February 17, 2017

Primary Completion

March 17, 2017

Study Completion

March 20, 2017

Last Updated

July 31, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)