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A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets

Primary Purpose

Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction

Status
Active
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
SHR7280 tablets
SHR7280 dry suspension
Sponsored by
Jiangsu HengRui Medicine Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial; Age 18~45 years old (including both end values, subject to the signing of informed consent); Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 18~30 kg/m2 (including both end values); Those who have no birth plan and no sperm or egg donation plan within 1 week after signing the informed consent form and the last dose, and agree to use highly effective contraceptive measures; Women have regular menstruation in the last 3 days before the screening visit, with a menstrual cycle of 24~35 days and a menstrual period of 3~7 days. Exclusion Criteria: Female screening period or baseline period (D-1) urine pregnancy test or serum pregnancy test (serum β-HCG test) results are positive; The female had any form of pregnancy (including spontaneous abortion, childbirth, ectopic pregnancy, etc.) within 3 months before randomization, or was breastfeeding at the time of the screening visit; Women found ovarian cysts or masses with a diameter of ≥ 4 cm during the screening period; Women use the following contraceptive methods during screening visits: drug sustained-release IUD, sustained-release contraceptives (subcutaneous implants, vaginal rings, microspheres and microcapsule contraceptive injections); Use of long-acting contraceptive injections before screening (contraindicated 3 months before screening for medroxyprogesterone acetate and 1 month before screening for other injections), oral contraceptives 2 months before screening, and contraceptives 1 month before screening; Special circumstances are judged by the investigator; Those with a history of tobacco addiction in the previous 3 months (an average daily smoking > 5); Average daily alcohol intake of more than 25 g (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) in the 3 months prior to randomization; Consumed any drink or food containing grapefruit within 7 days prior to randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization; Allergic constitution, or suspected allergy to any ingredient in SHR7280 preparation; Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (methylenedioxyamphetamine), marijuana (tetrahydrocannabinolic acid); Have a history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to a history of circulatory, endocrine, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic diseases; QTcF > 450 ms at screening or baseline 12-lead ECG (maximum retest 2 times allowed, average value can be taken), or there are other abnormalities judged by the investigator to be clinically significant; Vital signs, physical examination, laboratory tests, abdominal ultrasound or chest imaging at screening, etc., suggest that there are abnormalities that are judged to be clinically significant by the investigator; Within 4 weeks before randomization, positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV) antibody, or positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody; Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization; Those who have participated in clinical trials of any other drug or medical device within 3 months before randomization or within 5 half-lives of the drug (subject to whether to administer or use the device); Have received BCG vaccine within 12 months prior to screening; or vaccination or exposure to other live vaccines or live attenuated vaccines (except COVID vaccines) within 3 months prior to randomization; or those who plan to be vaccinated during the trial; Those who have undergone any surgery within the 3 months prior to randomization, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period; Those who donate blood (or blood loss) within 3 months of randomization and donate blood (or blood loss) in an amount ≥ 400 mL, or receive blood transfusion; The subject is judged by the investigator to have circumstances that affect the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or other factors that are not suitable to participate in this study.

Sites / Locations

  • The Second Affiliated Hospital of Guangzhou Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment group ARM 1

Treatment group ARM 2

Arm Description

SHR7280 dry suspension then SHR7280 tablets

SHR7280 tablets, then SHR7280 dry suspension

Outcomes

Primary Outcome Measures

SHR7280 and its main Pk parameter AUC0-t
SHR7280 and its main Pk parameter AUC0-∞
SHR7280 and its main Pk parameter Cmax
Relative bioavailability (F%) value between SHR7280 dry suspension and SHR7280 tablet: F% = AUC0-t (dry suspension) / AUC0-t (tablet) ×100%

Secondary Outcome Measures

SHR7280 and its main Pk parameter Tmax (SHR7280 only)
SHR7280 and its main Pk parameter t1/2 (SHR7280 only)
SHR7280 and its main Pk parameter CL/F (SHR7280 only)
SHR7280 and its main Pk parameter Vz/F (SHR7280 only)
Adverse events

Full Information

First Posted
May 11, 2023
Last Updated
June 19, 2023
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05868057
Brief Title
A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets
Official Title
Clinical Studies Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets (Single-center, Randomized, Open-label, Crossover)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 23, 2023 (Actual)
Primary Completion Date
October 15, 2023 (Anticipated)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To assess the relative bioavailability of SHR7280 dry suspension and tablets in healthy subjects. To assess the safety and tolerability of a single dose of SHR7280 dry suspension and tablets.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometriosis, Uterine Fibroids, Male Hormone-sensitive Prostate Cancer, Assisted Reproduction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment group ARM 1
Arm Type
Experimental
Arm Description
SHR7280 dry suspension then SHR7280 tablets
Arm Title
Treatment group ARM 2
Arm Type
Experimental
Arm Description
SHR7280 tablets, then SHR7280 dry suspension
Intervention Type
Drug
Intervention Name(s)
SHR7280 tablets
Intervention Description
SHR7280 tablets 1 time
Intervention Type
Drug
Intervention Name(s)
SHR7280 dry suspension
Intervention Description
SHR7280 dry suspension 1 time
Primary Outcome Measure Information:
Title
SHR7280 and its main Pk parameter AUC0-t
Time Frame
Day 1 to Day 5
Title
SHR7280 and its main Pk parameter AUC0-∞
Time Frame
Day 1 to Day 5
Title
SHR7280 and its main Pk parameter Cmax
Time Frame
Day 1 to Day 5
Title
Relative bioavailability (F%) value between SHR7280 dry suspension and SHR7280 tablet: F% = AUC0-t (dry suspension) / AUC0-t (tablet) ×100%
Time Frame
Day 1 to Day 5
Secondary Outcome Measure Information:
Title
SHR7280 and its main Pk parameter Tmax (SHR7280 only)
Time Frame
Day 1 to Day 5
Title
SHR7280 and its main Pk parameter t1/2 (SHR7280 only)
Time Frame
Day 1 to Day 5
Title
SHR7280 and its main Pk parameter CL/F (SHR7280 only)
Time Frame
Day 1 to Day 5
Title
SHR7280 and its main Pk parameter Vz/F (SHR7280 only)
Time Frame
Day 1 to Day 5
Title
Adverse events
Time Frame
Day 1 to Day 10

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Voluntarily sign the informed consent form before the start of the activities related to the trial, and be able to understand the procedures and methods of the trial, and be willing to strictly abide by the clinical trial protocol to complete the trial; Age 18~45 years old (including both end values, subject to the signing of informed consent); Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 18~30 kg/m2 (including both end values); Those who have no birth plan and no sperm or egg donation plan within 1 week after signing the informed consent form and the last dose, and agree to use highly effective contraceptive measures; Women have regular menstruation in the last 3 days before the screening visit, with a menstrual cycle of 24~35 days and a menstrual period of 3~7 days. Exclusion Criteria: Female screening period or baseline period (D-1) urine pregnancy test or serum pregnancy test (serum β-HCG test) results are positive; The female had any form of pregnancy (including spontaneous abortion, childbirth, ectopic pregnancy, etc.) within 3 months before randomization, or was breastfeeding at the time of the screening visit; Women found ovarian cysts or masses with a diameter of ≥ 4 cm during the screening period; Women use the following contraceptive methods during screening visits: drug sustained-release IUD, sustained-release contraceptives (subcutaneous implants, vaginal rings, microspheres and microcapsule contraceptive injections); Use of long-acting contraceptive injections before screening (contraindicated 3 months before screening for medroxyprogesterone acetate and 1 month before screening for other injections), oral contraceptives 2 months before screening, and contraceptives 1 month before screening; Special circumstances are judged by the investigator; Those with a history of tobacco addiction in the previous 3 months (an average daily smoking > 5); Average daily alcohol intake of more than 25 g (e.g., 750 mL of beer, 250 mL of wine, or 50 mL of liquor) in the 3 months prior to randomization; Consumed any drink or food containing grapefruit within 7 days prior to randomization; or eat any beverage or food containing methylxanthines, such as coffee, tea, cola, chocolate, etc., within 2 days before randomization; Allergic constitution, or suspected allergy to any ingredient in SHR7280 preparation; Drug abusers, or positive urine drug abuse screening at screening, including: morphine, meth (methamphetamine), ketamine, cocaine, ecstasy (methylenedioxyamphetamine), marijuana (tetrahydrocannabinolic acid); Have a history of any clinically serious disease or disease or condition that the investigator believes may affect the test results, including but not limited to a history of circulatory, endocrine, nervous system, digestive system, urinary system or blood, immune, psychiatric and metabolic diseases; QTcF > 450 ms at screening or baseline 12-lead ECG (maximum retest 2 times allowed, average value can be taken), or there are other abnormalities judged by the investigator to be clinically significant; Vital signs, physical examination, laboratory tests, abdominal ultrasound or chest imaging at screening, etc., suggest that there are abnormalities that are judged to be clinically significant by the investigator; Within 4 weeks before randomization, positive hepatitis B surface antigen (HBsAg), or positive anti-hepatitis C virus (HCV) antibody, or positive human immunodeficiency virus (HIV) antibody, or positive syphilis antibody; Use of any prescription drug, over-the-counter drug, Chinese herbal medicine or dietary supplement within 2 weeks prior to randomization; Those who have participated in clinical trials of any other drug or medical device within 3 months before randomization or within 5 half-lives of the drug (subject to whether to administer or use the device); Have received BCG vaccine within 12 months prior to screening; or vaccination or exposure to other live vaccines or live attenuated vaccines (except COVID vaccines) within 3 months prior to randomization; or those who plan to be vaccinated during the trial; Those who have undergone any surgery within the 3 months prior to randomization, or who have not recovered after surgery, or who may have surgery or hospitalization plans during the estimated trial period; Those who donate blood (or blood loss) within 3 months of randomization and donate blood (or blood loss) in an amount ≥ 400 mL, or receive blood transfusion; The subject is judged by the investigator to have circumstances that affect the absorption, distribution, metabolism and excretion of the drug or can reduce compliance or other factors that are not suitable to participate in this study.
Facility Information:
Facility Name
The Second Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511447
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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A Clinical Study Evaluating the Relative Bioavailability of SHR7280 Dry Suspension and Tablets

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