Study to Investigate Relative Bioavailability of Different Formulations of SHR6390 in Healthy Subjects

A Single-centre, Single Dose, Randomized, Open-label, Three Period, Six Sequence, Cross Controlled Study to Assess the Relative Bioavailability of the New and Traditional Formulations on SHR6390 in Healthy Subjects

The purpose of this study is to investigate relative bioavailability during the new and traditional formulations of SHR6390 in healthy subjects

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: SHR6390

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 470071
      • Zhongnan Hospital of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Execute an informed consent;
2. Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
3. Male body weight ≥ 50 kg, female body weight ≥ 45 kg, body mass index (BMI) in the range of 19.0-26.0 kg / m2 (including the critical value);
4. Physical examination, vital signs, laboratory examination , 12-Lead ECG, abdominal B-ultrasound, chest X-ray, etc. are normal or abnormal, but the researcher has no clinical significance according to NCI CTCAE 5.0 standard;
5. Fertile subjects had no family planning and had to take acceptable contraceptive measures and no plans to donate eggs and sperm within 7 months from the date of signing informed consent to the last medication; the serum pregnancy test of fertile women within 72 hours before the first administration of the study drug should be negative.

Exclusion Criteria:

1. Those who have previously suffered from primary diseases of important organs, including but not limited to neuropsychiatric, cardiovascular, digestive tract, respiratory system, urinary, endocrine, blood, immune and other diseases, which are judged by the researchers to be unsuitable for the trial;
2. Patients who have received any previous operation affecting gastrointestinal absorption;
3. Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
4. Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
5. HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
6. History of drug use or drug abuse, or drug screening positive;
7. Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
8. Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
9. Having swallowing resistance or disorder, affecting drug absorption;
10. Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
11. Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
12. Taking any prescription drug, over-the-counter drug, traditional Chinese medicine or food supplement within 2 weeks before taking the study drug for the first time;
13. Ingestion of grapefruit containing products, fruit juice, food or beverage containing methylxanthine or alcohol within 72 hours before taking the study drug for the first time; taking strenuous exercise; or having other factors affecting the absorption, distribution, metabolism and excretion of drugs;
14. Lactating women;
15. The researchers considered that the subjects had any other factors that were not suitable for the trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 traditional formulation (R) in the last period	Drug: SHR6390; SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Experimental: Sequence 2; Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 new formulation 2 (T2) in the last period	Drug: SHR6390; SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Experimental: Sequence 3; Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 1 (T1) in the last period	Drug: SHR6390; SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Experimental: Sequence 4; Intervention: Drug: SHR6390 new formulation 1(T1) in the first period; SHR6390 traditional formulation (R) in the second period; SHR6390 new formulation 2 (T2) in the last period	Drug: SHR6390; SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Experimental: Sequence 5; Intervention: Drug: SHR6390 new formulation 2(T2) in the first period; SHR6390 new formulation 1 (T1) in the second period; SHR6390 traditional formulation (R) in the last period	Drug: SHR6390; SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
Experimental: Sequence 6; Intervention: Drug: SHR6390 traditional formulation (R) in the first period; SHR6390 new formulation 2 (T2) in the second period; SHR6390 new formulation 1 (T1) in the last period	Drug: SHR6390; SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fr	Relative bioavailability of the two new formulations on SHR6390	Day1~Day35
Cmax	Maximum concentration of SHR6390	Day1~Day35
AUC0-t	Area under the concentration-time curve from time zero to time t of SHR6390	Day1~Day35
AUC0-∞	Area under the concentration-time curve extrapolated to infinity of SHR6390	Day1~Day35

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2020
• Primary Completion (Actual): January 29, 2021
• Study Completion (Actual): January 29, 2021

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 9, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): October 12, 2021
• Last Update Submitted That Met QC Criteria: October 11, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SHR6390-I-112

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No