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

NCT04667156 | Completed Phase 1

• 1 other identifier: SHR6390-I-112
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (6)

Sequence 1

EXPERIMENTAL

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

Sequence 2

EXPERIMENTAL

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

Sequence 3

EXPERIMENTAL

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

Sequence 4

EXPERIMENTAL

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

Sequence 5

EXPERIMENTAL

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

Sequence 6

EXPERIMENTAL

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

Interventions

SHR6390 DRUG

SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Execute an informed consent;
• Male or female aged 18-45 years (including threshold) on the date of signing the informed consent;
• 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);
• 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;
• 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.

You may not qualify if:

• 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;
• Patients who have received any previous operation affecting gastrointestinal absorption;
• Patients who had received any surgery within 6 months before screening, or planned to undergo surgery during the study period;
• Those who lost blood or donated more than 400 ml or received blood transfusion within 3 months before screening;
• HBsAg positive, HCV antibody positive, HIV antibody positive, syphilis antibody positive;
• History of drug use or drug abuse, or drug screening positive;
• Smoking and alcohol addict and unable to stop smoking during the test period; those with positive alcohol screening; those with positive nicotine screening;
• Allergic constitution, including severe drug allergy or drug allergy history; known allergy to shr6390 tablets or its excipients;
• Having swallowing resistance or disorder, affecting drug absorption;
• Participated in other clinical trials and taken the study drug within 3 months before taking the study drug for the first time;
• Inducers or inhibitors of CYP3A4, CYP2C9 and CYP2C8 were taken within 4 weeks before the first administration of study drug;
• 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;
• 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;
• Lactating women;
• The researchers considered that the subjects had any other factors that were not suitable for the trial.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, 470071, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2020
• First Posted: December 14, 2020
• Study Start: December 13, 2020
• Primary Completion: January 29, 2021
• Study Completion: January 29, 2021
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

CN (1)