The Pharmacokinetic(PK)/Pharmacodynamics(PD) Study of SHR7280 Tablets in Premenopausal Subjects With Endometriosis.

NCT ID: NCT04417972

Last Updated: 2024-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 179 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2024-05-14

Brief Summary

The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

Detailed Description

Endometriosis is a common disease, affecting 5-10% of women of reproductive age . It is an estrogen-dependent and estrogen-driven disease and so hormonal manipulation and suppression of estrogen production form the basis of the majority of medical treatment. The primary objective of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR7280 tablets in premenopausal subjects with endometriosis. In addition, this study will provide information on efficacy of SHR7280 tablets in premenopausal subjects with endometriosis.

Conditions

Endometriosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

SHR7280 dose 1

oral administration for 21days,Phase I

Group Type: EXPERIMENTAL

SHR7280

Intervention Type: DRUG

treatment

Placebo oral tablet

Intervention Type: DRUG

blank control

SHR7280 dose 2

oral administration for 21days,Phase I

Group Type: EXPERIMENTAL

SHR7280

Intervention Type: DRUG

treatment

Placebo oral tablet

Intervention Type: DRUG

blank control

SHR7280 dose 3

oral administration for 21days,Phase I

Group Type: EXPERIMENTAL

SHR7280

Intervention Type: DRUG

treatment

Placebo oral tablet

Intervention Type: DRUG

blank control

SHR7280 dose 4

oral administration for 21days,Phase I

Group Type: EXPERIMENTAL

SHR7280

Intervention Type: DRUG

treatment

Placebo oral tablet

Intervention Type: DRUG

blank control

SHR7280 low dose

oral administration for 84days,Phase II

Group Type: ACTIVE_COMPARATOR

SHR7280

Intervention Type: DRUG

treatment

SHR7280 high dose

oral administration for 84days, Phase II

Group Type: ACTIVE_COMPARATOR

SHR7280

Intervention Type: DRUG

treatment

Placebo

oral administration for 84days, Phase II

Group Type: PLACEBO_COMPARATOR

Placebo oral tablet

Intervention Type: DRUG

blank control

Interventions

SHR7280

treatment

Intervention Type: DRUG

Placebo oral tablet

blank control

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Phase I/II

1. premenopausal females, aged 18-45

2. History of regular menstrual cycles

3. Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.

4. Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.

5. Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on X-ray Phase I (only) Participant has mild or moderate pelvic pain associated with endometriosis at Screening.

Phase II(only) Participant has moderate or severe pelvic pain associated with endometriosis at Screening.

Exclusion Criteria

Phase I/II

1. Subjects with severe trauma or surgery within 6 months prior to the screening；

2. Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;

3. Pregnant or Serum β-human chorionic gonadotropin (hCG)> 5 Million International Units(mIU)/mL at screening or baseline

4. Pregnant or breast feeding ;

5. Have pelvic pain that is not caused by endometriosis

6. Abnormal uterine bleeding

7. Are currently receiving gonadotropin-releasing hormone (GnRH) agonist, a GnRH antagonist or danazol or have received any of these agents within 6 months of the start of screening.

8. Are currently receiving subcutaneous medroxyprogesterone acetate (DMPA-SC) or intramuscular medroxyprogesterone acetate (DMPA-IM) or have received any of these agents within 3 months of the start of screening.

9. Are currently using hormonal contraception or other forms of hormonal therapy or received such treatment within 2 months of the start of screening.

Phase I (only) one month prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs before screening; Phase II (only) Screening dual-energy x-ray absorptiometry (DXA) scan results of the lumbar spine, femoral neck, or total hip bone mineral density corresponding to 1.5 or more standard deviations below normal (T-score at or below -1.5)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongyan Guo, PhD

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

Peking University Third Hospital

Beijing, Beijing Municipality, China

Countries

China

References

Li Y, Zheng Y, Xu B, Cai L, Feng S, Liu Y, Zhu Z, Yu Q, Guo H. Safety, Pharmacokinetics, and Pharmacodynamics of SHR7280, a Non-peptide GnRH Antagonist in Premenopausal Women with Endometriosis: A Randomized, Double-Blind, Placebo-Controlled Phase 1 Study. Clin Pharmacokinet. 2023 Dec;62(12):1739-1748. doi: 10.1007/s40262-023-01315-6. Epub 2023 Oct 14.

Reference Type: DERIVED

PMID: 37838623 (View on PubMed)

Other Identifiers

SHR7280-102

Identifier Type: -

Identifier Source: org_study_id