Prostate Cancer
Conditions
Brief summary
The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.
Interventions
DRUGdegarelix
Sponsors
Ferring Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated * Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening * Has a screening serum testosterone level \>150 ng/dL * Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2
Exclusion criteria
* Has had previous or is currently under hormonal management of prostate cancer. However, hormonal therapy for a maximum duration of 6 months is accepted. This treatment should have been terminated at least 6 months prior to the Screening Visit * Is currently treated with a 5-alpha reductase inhibitor * Is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy * Is in need of neoadjuvant hormonal therapy * Has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum plasma concentration observed (Cmax) | Day 0 - 196 |
| Time of Cmax after subcutaneous administration (Tmax) | Day 0 - 196 |
| Area under the plasma concentration-time curve during a drug dosing interval (AUC) | Day 0 - 28 |
Secondary
| Measure | Time frame |
|---|---|
| Plasma trough levels of degarelix | At Days 28, 56, 168 and 196 |
Countries
China
Outcome results
None listed