A Study of Pharmacokinetic/Pharmacodynamic Profile of Orally Administered Leuprolide in Healthy Female Volunteers
Status:
Completed
Trial end date:
2018-06-18
Target enrollment:
Participant gender:
Summary
This Phase 2a, pharmacokinetic/pharmacodynamic study will determine the safety and provide
evaluation of the PK/PD metrics of three different oral doses selected upon the results of
the study LOPDT-PH1-01 - 4 mg oral tablets administered over 28 days as QD and BID regimens
and 10 mg oral tablets administered over 28 days as a BID regimen. The PK/PD profiles of the
study drug will be compared to the leuprolide formulation approved for the treatment of
endometriosis (a monthly intramuscular injection, Lupron Depot 3.75 mg). Major PK (e.g., a
total exposure to leuprolide) and PD parameters (e.g., rates of the estradiol suppression and
cessation of the menstrual period) will also be evaluated against the Lupron Depot historical
data.