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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04783636
Recruitment Status : Not yet recruiting
First Posted : March 5, 2021
Last Update Posted : March 17, 2021
Sponsor:
Information provided by (Responsible Party):
Peptron, Inc.

Study Description
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Brief Summary:
The purpose of study is to compare the safety and pharmacokinetics of PT105 with PT105R in healthy postmenopausal female volunteers

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: leuprorelin acetate 3.75mg Phase 1

Detailed Description:
The purpose of study is to confirm the safety and pharmacokinetics of PT105 in healthy postmenopausal female volunteers
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 11, 2021
Estimated Primary Completion Date : July 20, 2021
Estimated Study Completion Date : July 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
A
After a single administration of PT105R (leuprorelin acetate 3.75mg), a single administration of PT105 (leuprorelin acetate 3.75mg)
 Drug: leuprorelin acetate 3.75mg
PT105, PT105R
Other Name: PT105
B
After a single administration of PT105 (leuprorelin acetate 3.75mg), a single administration of PT105R (leuprorelin acetate 3.75mg)
 Drug: leuprorelin acetate 3.75mg
PT105, PT105R
Other Name: PT105


Outcome Measures
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Primary Outcome Measures :
  1. AUC7-t of Leuprolide [ Time Frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr ]
    AUC7-t

  2. AUCt of Leuprolide [ Time Frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr ]
    AUCt

  3. AUCinf of Leuprolide [ Time Frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr ]
    AUCinf

  4. Cmax of Leuprolide [ Time Frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr ]
    Cmax


Secondary Outcome Measures :
  1. Tmax of Leuprolide [ Time Frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr ]
    Tmax

  2. t1/2 of Leuprolide [ Time Frame: 0h, 0.5, 1, 2, 4, 8, 12, 24, 72, 168, 240, 336, 504, 672, 840, 1008 hr ]
    t1/2


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Responsible Party: Peptron, Inc.
ClinicalTrials.gov Identifier: NCT04783636    
Other Study ID Numbers: PT105-BE
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: March 17, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Leuprolide
 Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents