A Randomized, Open, Single-center, Two-cycle, Double-sequence Crossover Study to Investigate the Effects of a High-fat Diet on the Pharmacokinetics of Healthy Chinese Male Adult Subjects After Oral Administration of SHR2554 Tablets

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country20 target enrollmentAugust 6, 2019

ConditionsHealthy Adult Subjects

InterventionsSHR2554

DrugsSHR2554

Overview

Phase: Phase 1
Intervention: SHR2554
Conditions: Healthy Adult Subjects
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 20
Locations: 1
Primary Endpoint: Pharmacokinetics parameter: Cmax of SHR2554
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objective of the study is to evaluate the effect of high-fat diet on pharmacokinetics of healthy Chinese male adult subjects after oral administration of SHR2554 tablets.

The secondary objective of the study is to evaluate the safety of single dose of SHR2554 orally in healthy subjects.

Registry

clinicaltrials.gov

Start Date

August 6, 2019

End Date

March 30, 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Crossover

Sex

Male

Investigators

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Healthy male subjects aged 40\~60 at the date of signing the informed consent;
•Male body weight ≥ 50kg , body mass index (BMI) within the range of 19 \~ 28kg /m2 (including 19 and 28) (BMI= weight (kg)/height 2 (m2));
•During screening period physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation, abdominal ultrasound, chest X-ray and other examination results must be within the normal range consistent with age and gender, or in accordance with the protocol, or judged to be "no clinical significance (NCS)" if beyond the normal range;
•Agree to abstain from sex or use effective non-drug contraceptives from screening to at least 3 months after the last study drug administration (female subjects are also required to abstain or use effective non-drug contraceptives two weeks prior to study entry);
•The subject can communicate well with the researcher, understand and comply with the requirements of the study, understand and sign the informed consent.

Exclusion Criteria

•Allergic constitution or known allergy to the research drug/similar drugs;
•Frequent use of sedatives, sleeping pills or other addictive drugs; History of drug abuse within 6 months prior to first administration or drug abuse screening positive; Alcoholic or often drinkers within 6 months prior to screening, the average drinking amount is more than 14 units a week (1 unit= 285 ml beer or 25 ml alcohol content of 40% spirits or 100 ml wine), a heavy smoker or quitting time less than 3 months, alcohol breath test positive and nicotine test positive, and can't quit smoking and alcohol during the study;
•A history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia and stroke;
•Pulmonary diseases, including invasive lung disease, pneumonia, and dyspnoea;
•Chronic kidney disease, renal insufficiency, renal anaemia;
•A history of dysphagia or any gastrointestinal disease affecting drug absorption;
•Any uncontrolled peptic ulcer, colitis, pancreatitis, etc;
•Any operation within the previous 3 months that may affect the absorption, distribution, metabolism and excretion of drugs;
•Previous medical history of cardiovascular, liver, kidney, lung, digestive tract, nervous system diseases, etc., which may significantly affect the absorption, distribution, metabolism and excretion of drugs, or may pose a hazard to the subjects participating in the study. The following medical history or conditions should be considered: inflammatory gastroenteritis, gastroesophageal reflux, gastrointestinal or rectal bleeding; History of pancreatic injury or pancreatitis; Greater surgical history such as gastrectomy, gastroenterostomy, or enterectomy; History of acute and chronic renal insufficiency, history of renal transplantation;
•Taking any hepatotoxic drugs (such as dapsone, erythromycin, fluconazole, ketoconazole and rifampicin) in the months prior to screening;

Arms & Interventions

Treatment group A

Drug: SHR2554 fasted in P1, high-fat diet in P2 SHR2554 administration in fasted condition in period 1, SHR2554 administration after high-fat diet in period 2

Intervention: SHR2554

Treatment group B

Drug: SHR2554 high-fat diet in P1, fasted in P2 SHR2554 administration after high-fat diet in period 1, SHR2554 administration in fasted condition in period 2

Intervention: SHR2554