To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

Prostate Cancer Clinical Trial

Official title:

A Randomized, Open-label, Single-dosing, 2x2 Crossover Phase 1 Study to Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04783636
• Other study ID #: PT105-BE
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 11, 2021
• Est. completion date: July 20, 2021

Study information

• Verified date: March 2021
• Source: Peptron, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

Description:

The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 20, 2021
• Est. primary completion date: July 20, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• A healthy woman who is over 19 years of age and has been certified obstetrically with menopause, at the time of screening.

• Subjects weighing over 50 kg with BMI between 18 and 30 kg/m2 (inclusive) at screening visit.

Exclusion Criteria:

• Those who have clinical significant liver, kidney, nervous system, respiratory, endocrine, hematology and oncology, cardiovascular, urinary, and mental diseases or past history

• Those whose plasma AST and ALT exceed 2 times to the upper limit of the normal range in screening including additional examinations prior to randomization

• Subjects who have participated and taken investigational drug in any other clinical trial (including bioequivalence study) within six months prior to study drug administration

• Subjects who have donated a unit of whole blood within two months or blood components within one month prior to study drug administration

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• leuprorelin acetate 3.75mg
PT105, PT105R

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Peptron, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUC7-t of Leuprolide	AUC7-t	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Primary	AUCt of Leuprolide	AUCt	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Primary	AUCinf of Leuprolide	AUCinf	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Primary	Cmax of Leuprolide	Cmax	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Secondary	Tmax of Leuprolide	Tmax	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Secondary	t1/2 of Leuprolide	t1/2	0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr