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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554043
Other study ID # SHR7280-103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date September 11, 2020
Est. completion date September 28, 2021

Study information

Verified date October 2021
Source Jiangsu HengRui Medicine Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in healthy subjects.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 118
Est. completion date September 28, 2021
Est. primary completion date September 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: PART 1: 1. Healthy males , aged 18-65; 2. BMI 18 ~ 30 kg/m2; 3. Subjects in general good health. No clinically significant findings in Physical examination and auxiliary examination. PART 2: 1. premenopausal females, aged 18-45; 2. BMI 18 ~ 30 kg/m2; 3. Subjects in general good health. No clinically significant findings in Physical examination and auxiliary examination. Exclusion Criteria: PART 1 1. Testosterone (T) < 12 nmol/L; 2. ALT or AST or total bilirubin exceeds the upper limit of normal; 3. Those with positive nicotine test and alcohol breath test before administration, and those with positive drug screening before administration; 4. Use of any medication within 1 month before administration; or use of medication that does not exceed 5 half-lives, whichever is longer; 5. Subjects with chronic diseases or serious diseases that affect drug absorption, distribution, metabolism and excretion; 6. Blood donation or donation of blood components within 1 month before screening, or loss of blood equivalent to at least 200 mL, or transfusion within 2 months; 7. Use of GnRH agonists and GnRH antagonists within 6 months before screening and use of any androgens and antiandrogens within 5 half-lives before screening; 8. Subjects with severe infection, severe trauma or major surgery within 6 months before screening; 9. Positive results of infectious disease screening . 10. Allergic constitution or allergy to two or more kinds of food and drugs, including known history of allergy to the study drug or any component of the study drug. PART 2: 1. Pregnant or breast feeding; 2. FSH=25U/L; 3. Positive serum pregnancy test (serum ß-HCG test) result; 4. Abnormal uterine bleeding within 3 months prior to screening 5. ALT or AST or total bilirubin exceeds the upper limit of normal; 6. Those with positive nicotine test and alcohol breath test before administration, and those with positive drug screening before administration; 7. Use of any medication within 1 month before administration; or use of medication that does not exceed 5 half-lives, whichever is longer; 8. Subjects with chronic diseases or serious diseases that affect drug absorption, distribution, metabolism and excretion; 9. Blood donation or donation of blood components within 1 month before screening, or loss of blood equivalent to at least 200 mL, or transfusion within 2 months; 10. GnRH agonist use 6 months prior to Screening and GnRH antagonist or any sex hormone use 2 months prior to Screening. 11. Subjects with severe infection, severe trauma or major surgery within 6 months before screening 12. Positive results of infectious disease screening . 13. Allergic constitution or allergy to two or more kinds of food and drugs, including known history of allergy to the study drug or any component of the study drug.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
SHR7280
treatment
Placebo oral tablet
blank control

Locations

Country Name City State
China Affiliated Hospital of Qingdao University Qingdao Shan Dong

Sponsors (1)

Lead Sponsor Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants with Adverse events Part 1 and Part 2 Pre-dose to 28±2 days after dose administration
Secondary Area under the plasma concentration versus time curve (AUCt) after the first dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit( 28±2 days after dose administration)
Secondary Maximum observed serum concentration (Cmax) after the first dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Time to maximum observed serum concentration (Tmax) after the first dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Time to elimination half-life (T1/2) ; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Apparent total clearance(CL/F) of the drug from plasma after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Apparent volume of distribution(Vz/F) after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Maximum observed serum concentration (Cmax) after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Time to maximum observed serum concentration (Tmax) after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Trough observed serum concentration (Ctrough) after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Accumulation Factor(Racc)after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Area under the plasma concentration versus time curve (AUCt) after last morning dose of SHR7280; Part 1 and Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Endocrine Parameters: Testosterone Part 1 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Endocrine Parameters: Estuarial Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Endocrine Parameters:Progesterone Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Endocrine Parameters: Luteinizing hormone Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
Secondary Endocrine Parameters: Follicle stimulating hormone Part 2 At pre-defined intervals from initial dose through final study visit (28±2 days after dose administration)
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