Back to resultsTo Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
Primary Purpose
Prostate Cancer
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
leuprorelin acetate 3.75mg
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
A
B
Arm Description
After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)
After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg)
Outcomes
Primary Outcome Measures
AUC7-t of Leuprolide
AUC7-t
AUCt of Leuprolide
AUCt
AUCinf of Leuprolide
AUCinf
Cmax of Leuprolide
Cmax
Secondary Outcome Measures
Tmax of Leuprolide
Tmax
t1/2 of Leuprolide
t1/2
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04783636
Brief Title
To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 11, 2021 (Anticipated)
Primary Completion Date
July 20, 2021 (Anticipated)
Study Completion Date
July 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peptron, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers
Detailed Description
The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)
Arm Title
B
Arm Type
Other
Arm Description
After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg)
Intervention Type
Drug
Intervention Name(s)
leuprorelin acetate 3.75mg
Other Intervention Name(s)
PT105
Intervention Description
PT105, PT105R
Primary Outcome Measure Information:
Title
AUC7-t of Leuprolide
Description
AUC7-t
Time Frame
0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Title
AUCt of Leuprolide
Description
AUCt
Time Frame
0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Title
AUCinf of Leuprolide
Description
AUCinf
Time Frame
0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Title
Cmax of Leuprolide
Description
Cmax
Time Frame
0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Secondary Outcome Measure Information:
Title
Tmax of Leuprolide
Description
Tmax
Time Frame
0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
Title
t1/2 of Leuprolide
Description
t1/2
Time Frame
0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
To Compare the Safety and Pharmacokinetics of PT105 With PT105R in Healthy Postmenopausal Female Volunteers
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