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HealthyPhase 1NCT03034486

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

A Phase 1 study testing D930, D565 in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
D930, D565
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteSouth Korea
Study dates
17 Feb 2017to 20 Mar 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
  • 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
Show all 33Show fewer
  • 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
  • 2. 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.
  • 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
  • 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
  • ALT or AST> 2 times upper limit of normal range
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Dong-A University Hospital

    Seo-gu, Busan, 602-715

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Conditions
Healthy
Being tested
D930, D565
Keywords
Glaucoma
Medical subject headings
Glaucoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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

Study groups in NCT03034486
Study groupRoleWhat they receive
A single sequence, 3-periodExperimentalNot described
Receives: Drug: D930, D565

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCtau,ss of D930

    Measured: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

  2. Cmax,ss of D930

    Measured: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

Secondary outcomes (9)

  1. AUCt of D565

    Measured: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h

  2. Cmax of D565

    Measured: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h

  3. Tmax of D565

    Measured: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h

  4. t1/2 of D565

    Measured: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h

  5. AUCinf of D565

    Measured: predose (0 h), 1min, 3min, 5min, 10min, 15min, 20min, 40min, 1, 2, 4 h

  6. Ctrough, ss of D930

    Measured: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

  7. Tmax,ss of D930

    Measured: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

  8. t1/2 of D930

    Measured: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

  9. AUCinf of D930

    Measured: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2017 (estimated)
  2. Study start17 Feb 2017
  3. Primary completion17 Mar 2017
  4. Study completion20 Mar 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03034486
Sponsor's protocol ID
171DDI16019
Status last verified
Jul 2017
First submitted
25 Jan 2017
Last updated
31 Jul 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing D930, D565 in people with Healthy, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCtau,ss of D930 (time frame: predose (0 h), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 8, 12, 24 h). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03034486.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2017.

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