Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following SC Administration of DWJ108J in Patients With Prostate Cancer

January 20, 2017 updated by: Daewoong Pharmaceutical Co. LTD.

An Open Label, Randomized, Single Dose, Parallel-group, Phase 1 Study to Evaluate the Pharmacokinetics and Safety Following Subcutaneous Administration of DWJ108J in Patients With Prostate Cancer

The purpose of this study is to evaluate the pharmacokinetic characteristics and safety of DWJ108J (leuprolide acetate) and Leuplin DPS Inj administered subcutaneously in patients with prostate cancer

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  1. Males ≥19 and ≤80 years of age at Screening.
  2. Subject with histologically proven adenocarcinoma of the prostate requiring androgen deprivation therapy
  3. An ECOG performance status grade of 0 to 2,
  4. 19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening.

Exclusion Criteria:

  1. Confirmed Hormone refractory prostate cancer(HRPC)
  2. Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy.
  3. Diagnosed pituitary adenoma
  4. Has a history of depression
  5. Has a risk of spinal cor d compression due to metastatic spinal cord injury.
  6. Has a severe urethratresia.
  7. Confirmed uncontrolled Congestive heart failure (CHF) within 6 months of Screening.
  8. Has a history of MI or any procedure with regard to coronary artery disease within 6 months of Screening. (e.g., balloon angioplasty, coronary artery bypass graft)
  9. Has any severe concomitant disease that would interfere with the conduct of the study except for prostate cancer
  10. Has allergy history of leuprolide acetate, similar GnRH drugs or other medications (e.g., Aspirin, antibiotics) and/or has any allergic disease requiring treatment.
  11. Has received an investigational drug within 9 0days of Screening.
  12. Drug releasing is expected after administration of study drug, if subject received GnRH agonist for treatment of prostate cancer.
  13. Has other chemotherapy planned within 14weeks from administration of study drug, except for androgen deprivation therapy.
  14. Has no willing of using method of contraception throughout the study period.
  15. Systolic Blood Pressure < 90mmHg and/or ≥160mmHg or Diastolic Blood Pressure < 60mmHg and/or ≥100mmHg at Screening
  16. QTcF >450msec at Screening ECG.
  17. HbA1c level is high the upper limit of normal of reference range.
  18. Serum AST, ALT or Creatinine > 1.5times the upper limit of normal at Screening.
  19. Positive results of tests for hepatitis B, hepatitis C, HIV or syphilis.
  20. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: DWJ108J (leuprolide acetate)
Drug: Leuprolide Acetate
DWJ108J, SC injection, once(Day1)
Other Names:
  • DWJ108J
Drug: Leuprolide Acetate
Leuplin DPS Inj, SC injection, once(Day1)
Other Names:
  • Leuplin DPS Inj
Active Comparator: Leuplin DPS Inj
Drug: Leuprolide Acetate
DWJ108J, SC injection, once(Day1)
Other Names:
  • DWJ108J
Drug: Leuprolide Acetate
Leuplin DPS Inj, SC injection, once(Day1)
Other Names:
  • Leuplin DPS Inj

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Peak Plasma Concentration (Cmax)
Time Frame: Day 99
Day 99
Area under the plasma concentration versus time curve (AUC)
Time Frame: Day 99
AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf
Day 99

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Daewoong Pharmaceutical Co. LTD.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 24, 2017

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 24, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DW_LP3M002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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