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

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

44

Phase

  • 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

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
Intervention / Treatment
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

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

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

February 1, 2017

Primary Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Estimate)

January 24, 2017

Last Update Submitted That Met QC Criteria

January 20, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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