The PK/PD Study of SHR7280 Tablets in Healthy Subjects.
NCT ID: NCT04554043
Last Updated: 2021-10-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
118 participants
INTERVENTIONAL
2020-09-11
2021-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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SHR7280 dose 1(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 2(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 3(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 4(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 5(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 1(female)
oral administration for 21 days,Phase I(PART 2)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 2(female)
oral administration for 21 days,Phase I(PART 2)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 3(female)
oral administration for 21 days,Phase I(PART 2)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 4(female)
oral administration for 21 days,Phase I(PART 2)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 6(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
SHR7280 dose 7(male)
oral administration for 14 days,Phase I(PART 1)
SHR7280
treatment
Placebo oral tablet
blank control
Interventions
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SHR7280
treatment
Placebo oral tablet
blank control
Eligibility Criteria
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Inclusion Criteria
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
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 β-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.
18 Years
65 Years
ALL
Yes
Sponsors
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Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Yu Cao, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital of Qingdao University
Locations
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Affiliated Hospital of Qingdao University
Qingdao, Shandong, China
Countries
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References
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Li X, Sun F, Zhang X, Lin P, Shen K, Shen Y, Ma L, Cao Y, Wang C. Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone receptor antagonist, in healthy men: a randomized, double-blind, placebo-controlled phase 1 study. BMC Med. 2023 Apr 3;21(1):129. doi: 10.1186/s12916-023-02834-6.
Xu Y, Hu W, Li J, Jiang X, Shi P, Shen K, Shen Y, Ma L, Cao Y. Safety, pharmacokinetics, and pharmacodynamics of SHR7280, an oral gonadotropin-releasing hormone antagonist in healthy premenopausal women. Front Pharmacol. 2022 Nov 23;13:1027648. doi: 10.3389/fphar.2022.1027648. eCollection 2022.
Other Identifiers
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SHR7280-103
Identifier Type: -
Identifier Source: org_study_id