The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects.
GNRH antagonists can be used to treat sex hormone-dependent diseases, and SHR7280 is an oral GNRH antagonist. The purpose of this study is to observe the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of SHR7280 in healthy subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
118
treatment
blank control
Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Number of Participants with Adverse events
Part 1 and Part 2
Time frame: Pre-dose to 28±2 days after dose administration
Area under the plasma concentration versus time curve (AUCτ) after the first dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit( 28±2 days after dose administration)
Maximum observed serum concentration (Cmax) after the first dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Time to maximum observed serum concentration (Tmax) after the first dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Time to elimination half-life (T1/2) ;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Apparent total clearance(CL/F) of the drug from plasma after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Apparent volume of distribution(Vz/F) after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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Maximum observed serum concentration (Cmax) after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Time to maximum observed serum concentration (Tmax) after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Trough observed serum concentration (Ctrough) after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Accumulation Factor(Racc)after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Area under the plasma concentration versus time curve (AUCτ) after last morning dose of SHR7280;
Part 1 and Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters: Testosterone
Part 1
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters: Estuarial
Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters:Progesterone
Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters: Luteinizing hormone
Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Endocrine Parameters: Follicle stimulating hormone
Part 2
Time frame: At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)