Comparison of a Novel Leuprolide With Market Leuprolide

Prostate Cancer Clinical Trial

Official title:

Evaluation of the Testosterone Suppressive Effect in Healthy Male Volunteers of a Novel Leuprolide Acetate 3.75mg Depot (Lutrate) VS Market Reference Leuprolide Acetate 3.75mg Depot (Enantone)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03662958
• Other study ID #: ZK-LUT-201802
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2018
• Est. completion date: December 2018

Study information

• Verified date: September 2018
• Source: Lee's Pharmaceutical Limited
• Contact: Hongju Wang, MD
• Phone: 0552-3086026
• Email: wanghongju[@]bbmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Drug:
• Lutrate
a novel leuprolide acetate 3.75mg depot
• Enantone
market reference leuprolide acetate 3.75 mg depot

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui

Sponsors (1)

Lead Sponsor	Collaborator
Lee's Pharmaceutical Limited

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events		4 weeks
Other	Local tolerability	(10) Subjects will evaluate pain with VAS. Investigators will evaluate redness and induration with a 4-point scale.	post-dose 5 min and 1 hour, day 8, 15 and 29
Other	AE		4 weeks
Other	blood pressure		4 weeks
Other	pulse rate		4 weeks
Other	respiratory rate		4 weeks
Other	body temperature		4 weeks
Other	12-lead ECG		4 weeks
Other	body weight		4 weeks
Primary	The rate of castration at the end of week 4 (i.e. day 29)		4 weeks
Secondary	The time to castration (i.e Tlag) between the 2 groups after administration of leuprolide		4 weeks
Secondary	The duration of castration (i.e Tcast)		4 weeks
Secondary	LH concentration		4 weeks
Secondary	FSH concentration		4 weeks