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

NCT04417972 | Completed Phase 1

• 1 other identifier: SHR7280-102
• Study Type: interventional
• Target: 179
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Adverse events

  Phase I

  Pre-dose to 28±2 days after dose administration

• Change From Baseline in the 7-day mean score for pelvic pain as measured by VAS at weeks 12

  Phase II daily assessment of dysmenorrhea score on a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) using an e-Diary.

  Baseline and weeks 12

Secondary Outcomes (17)

• PK markers of SHR7280: area under the plasma concentration versus time curve (AUC)

  At pre-defined intervals from initial dose through final study visit

• PK markers of SHR7280: time to maximum plasma concentration(Tmax)

  At pre-defined intervals from initial dose through final study visit

• PK markers of SHR7280: maximum plasma concentration(Cmax)

  At pre-defined intervals from initial dose through final study visit

• PK markers of SHR7280: half-time(t1/2)

  At pre-defined intervals from initial dose through final study visit

• PK markers of SHR7280: apparent clearance(CL/F)

  At pre-defined intervals from initial dose through final study visit

Study Arms (7)

SHR7280 dose 1

EXPERIMENTAL

oral administration for 21days,Phase I

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 2

EXPERIMENTAL

oral administration for 21days,Phase I

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 3

EXPERIMENTAL

oral administration for 21days,Phase I

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 dose 4

EXPERIMENTAL

oral administration for 21days,Phase I

Drug: SHR7280; Drug: Placebo oral tablet

SHR7280 low dose

ACTIVE COMPARATOR

oral administration for 84days,Phase II

Drug: SHR7280

SHR7280 high dose

ACTIVE COMPARATOR

oral administration for 84days, Phase II

Drug: SHR7280

Placebo

PLACEBO COMPARATOR

oral administration for 84days, Phase II

Drug: Placebo oral tablet

Interventions

SHR7280 DRUG

treatment

SHR7280 dose 1; SHR7280 dose 2; SHR7280 dose 3; SHR7280 dose 4; SHR7280 high dose; SHR7280 low dose

Placebo oral tablet DRUG

blank control

Placebo; SHR7280 dose 1; SHR7280 dose 2; SHR7280 dose 3; SHR7280 dose 4

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Phase I/II
• premenopausal females, aged 18-45
• History of regular menstrual cycles
• Endometriosis participant diagnosed by surgical (e.g., laparoscopy or laparotomy) or by magnetic resonance imaging or ultrasonography.
• Participant must agree to use only protocol specified rescue analgesics during the Screening and Treatment Periods for endometriosis-associated pain.
• 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.

You may not qualify if:

• Phase I/II
• Subjects with severe trauma or surgery within 6 months prior to the screening；
• Known blood donation within 30 days pre-dose; donating≥200 ml of blood 2 months pre-dose;
• Pregnant or Serum β-human chorionic gonadotropin (hCG)\> 5 Million International Units(mIU)/mL at screening or baseline
• Pregnant or breast feeding ;
• Have pelvic pain that is not caused by endometriosis
• Abnormal uterine bleeding
• 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.
• 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.
• 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)

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, China

Location

Related Publications (1)

• 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.

  PMID: 37838623 DERIVED

MeSH Terms

Conditions

Endometriosis

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Hongyan Guo, PhD

  Peking University Third Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: June 5, 2020
• Study Start: July 30, 2020
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: July 8, 2024

Record last verified: 2024-07

Locations

CN (1)