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

Primary Purpose

Prostate Cancer

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Leuprolide Acetate

About this trial

This is an interventional treatment trial for Prostate Cancer

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DWJ108J (leuprolide acetate)

Leuplin DPS Inj

Arm Description

DWJ108J (leuprolide acetate)

Leuplin DPS Inj

Outcomes

Primary Outcome Measures

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf

Secondary Outcome Measures

Full Information

NCT ID

NCT03029533

First Posted

January 12, 2017

Last Updated

January 20, 2017

Sponsor

Daewoong Pharmaceutical Co. LTD.

1. Study Identification

Unique Protocol Identification Number

NCT03029533

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Unknown status

Study Start Date

February 2017 (undefined)

Primary Completion Date

November 2017 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daewoong Pharmaceutical Co. LTD.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DWJ108J (leuprolide acetate)

Arm Type

Experimental

Arm Description

DWJ108J (leuprolide acetate)

Arm Title

Leuplin DPS Inj

Arm Type

Active Comparator

Arm Description

Leuplin DPS Inj

Intervention Type

Drug

Intervention Name(s)

Leuprolide Acetate

Other Intervention Name(s)

DWJ108J

Intervention Description

DWJ108J, SC injection, once(Day1)

Intervention Type

Drug

Intervention Name(s)

Leuprolide Acetate

Other Intervention Name(s)

Leuplin DPS Inj

Intervention Description

Leuplin DPS Inj, SC injection, once(Day1)

Primary Outcome Measure Information:

Title

Peak Plasma Concentration (Cmax)

Time Frame

Day 99

Title

Area under the plasma concentration versus time curve (AUC)

Description

AUC0-7, AUC7-28, AUC 0-42, AUCt, AUCinf

Time Frame

Day 99

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males ≥19 and ≤80 years of age at Screening. Subject with histologically proven adenocarcinoma of the prostate requiring androgen deprivation therapy An ECOG performance status grade of 0 to 2, 19kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening. Exclusion Criteria: Confirmed Hormone refractory prostate cancer(HRPC) Has had history of bilateral orchiectomy, suprarenalectomy or hypophysectomy. Diagnosed pituitary adenoma Has a history of depression Has a risk of spinal cor d compression due to metastatic spinal cord injury. Has a severe urethratresia. Confirmed uncontrolled Congestive heart failure (CHF) within 6 months of Screening. 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) Has any severe concomitant disease that would interfere with the conduct of the study except for prostate cancer Has allergy history of leuprolide acetate, similar GnRH drugs or other medications (e.g., Aspirin, antibiotics) and/or has any allergic disease requiring treatment. Has received an investigational drug within 9 0days of Screening. Drug releasing is expected after administration of study drug, if subject received GnRH agonist for treatment of prostate cancer. Has other chemotherapy planned within 14weeks from administration of study drug, except for androgen deprivation therapy. Has no willing of using method of contraception throughout the study period. Systolic Blood Pressure < 90mmHg and/or ≥160mmHg or Diastolic Blood Pressure < 60mmHg and/or ≥100mmHg at Screening QTcF >450msec at Screening ECG. HbA1c level is high the upper limit of normal of reference range. Serum AST, ALT or Creatinine > 1.5times the upper limit of normal at Screening. Positive results of tests for hepatitis B, hepatitis C, HIV or syphilis. Has any condition that, in the opinion of the investigator, would make participation not be in the best interest of the subject.

12. IPD Sharing Statement

Learn more about this trial

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

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