Prostate Cancer
Conditions
Brief summary
This is a single dose, randomized, single blind, parallel group study to evaluate the testosterone suppressive effect in healthy male volunteers of a novel leuprolide acetate 3.75mg depot vs market reference leuprolide acetate 3.75mg depot. The safety, tolerability and the pharmacokinetic properties of the investigational drug and the control drug will also be assessed.
Interventions
DRUGLutrate
a novel leuprolide acetate 3.75mg depot
DRUGEnantone
market reference leuprolide acetate 3.75 mg depot
Sponsors
Lee's Pharmaceutical Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Males of 18-40 years old (inclusive). The age difference of subjects within and between groups should be less than 10 years, at the time of screening. 2. Body weight of at least 50kg. BMI to be 19-24 kg/m2 (inclusive). 3. Able to comprehend the full nature and purpose of the study, including potential risks and side effects; able to cooperate with investigators and to comply with the requirements of the study 4. Signed informed consent form prior to any screening procedures
Exclusion criteria
1. Clinically significant and relevant history of cardiovascular, hepatic, renal, hematologic, endocrine, respiratory, neurological diseases or acute/chronic diseases of the digestive tract. 2. History of hypersensitivity towards leuprolide, synthetic LHRH or LHRH derivatives or any excipients of the study formulation. 3. Abnormal and clinically significant 12-lead ECG 4. Abnormal and clinically significant laboratory assessments 5. Blood donation or blood loss greater than or equal to 400mL within 3 months prior to screening 6. Participation of clinical trials within 3 months prior to screening 7. Use of any drugs within 2 weeks prior to screening 8. History of drug abuse within 1 year prior to screening 9. History of alcohol abuse within 1 years prior to screening 10. History of tobacco smoking (more than 5 cigarette per day) within 1 year prior to screening 11. Abnormal testosterone level at screening (not in the range of 168-781ng/dL) 12. Dermatitis or skin anomalies that might affect the administration area and the surroundings 13. Subject or his partner not willing to adopt appropriate contraceptive measures 14. Subjects have a history of depressive illness or sexual dysfunction; 15. Subjects that the investigator deems unsuitable to be enrolled 16. Subject not willing to cooperate with the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of castration at the end of week 4 (i.e. day 29) | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide | 4 weeks |
| The duration of castration (i.e Tcast) | 4 weeks |
| LH concentration | 4 weeks |
| FSH concentration | 4 weeks |
Other
| Measure | Time frame | Description |
|---|---|---|
| respiratory rate | 4 weeks | — |
| body temperature | 4 weeks | — |
| Adverse events | 4 weeks | — |
| body weight | 4 weeks | — |
| 12-lead ECG | 4 weeks | — |
| Local tolerability | post-dose 5 min and 1 hour, day 8, 15 and 29 | (10) Subjects will evaluate pain with VAS. Investigators will evaluate redness and induration with a 4-point scale. |
| AE | 4 weeks | — |
| blood pressure | 4 weeks | — |
| pulse rate | 4 weeks | — |
Countries
China
Contacts
Primary ContactHongju Wang, MD
Outcome results
None listed