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

NCT03029533 | Unknown Phase 1

• 1 other identifier: DW_LP3M002
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Peak Plasma Concentration (Cmax)

  Day 99

• Area under the plasma concentration versus time curve (AUC)

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

  Day 99

Study Arms (2)

DWJ108J (leuprolide acetate)

EXPERIMENTAL

DWJ108J (leuprolide acetate)

Drug: Leuprolide Acetate

Leuplin DPS Inj

ACTIVE COMPARATOR

Leuplin DPS Inj

Drug: Leuprolide Acetate

Interventions

Leuprolide Acetate DRUG

DWJ108J, SC injection, once(Day1)

Also known as: DWJ108J

DWJ108J (leuprolide acetate)

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• kg/m2≤ Body Mass Index (BMI) ≤30kg/m2 at Screening.

You may not qualify if:

• 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

Sponsors & Collaborators

• Daewoong Pharmaceutical Co. LTD.: lead

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: January 24, 2017
• Study Start: February 1, 2017
• Primary Completion: November 1, 2017
• Last Updated: January 24, 2017

Record last verified: 2017-01