Pharmacokinetic Test of High-fat Diet After Oral Administration of SHR2554 in Healthy Subjects

NCT05592262 | Completed Phase 1

• 1 other identifier: SHR2554-I-109
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess the effect of food on the pharmacokinetics, and safety of SHR2554 Tablets in healthy subjects.

Conditions

Malignant Tumor

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetic parameters of SHR2554: Cmax

  day 1 to day 10

• Pharmacokinetic parameters of SHR2554: AUC0-t

  day 1 to day 10

• Pharmacokinetic parameters of SHR2554: AUC0-∞ (if applicable)

  day 1 to day 10

Secondary Outcomes (5)

• Pharmacokinetic parameters of SHR2554: Tmax

  day 1 to day 10

• Pharmacokinetic parameters of SHR2554: t1/2

  day 1 to day 10

• Pharmacokinetic parameters of SHR2554: CL/F

  day 1 to day 10

• Pharmacokinetic parameters of SHR2554: Vz/F

  day 1 to day 10

• The incidence and severity of adverse events/serious adverse events.

  from ICF signing date to approximate day 17

Study Arms (2)

Treatment group A

EXPERIMENTAL

Drug: SHR2554

Treatment group B

EXPERIMENTAL

Drug: SHR2554

Interventions

SHR2554 DRUG

On an empty stomach - after meals

Treatment group A

Eligibility Criteria

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

You may qualify if:

• Healthy male and female subjects aged between 18 and 45 (inclusive) at the time of signing the informed consent;
• Body weight ≥ 50.0 kg for men and body weight ≥ 45.0 kg for women, and body mass index (BMI) within the range of 19.0 to 26.0 kg /m2 (inclusive);
• The mean value of three 12-lead ECG tests was normal or abnormal but not clinically significant, the time limit from Q wave to T wave was \< 430 msec for male (QTcF), and \< 450 msec for female (QTcF), and the heart rate was in the normal range or abnormal but not clinically significant.
• Creatinine clearance (CLCr) ≥80 mL/min, and creatinine is less than or equal to the upper limit of normal value;
• Participants should have no fertility plan from signing the informed consent until 6 months after the last medication, take effective contraceptive measures voluntarily and have no sperm donation plan. The serum HCG test of fertile women must be negative before Screening;
• Participants should sign the informed consent before the study, and fully understand the content, process and possible adverse reactions of the study.

You may not qualify if:

• Patients with abnormal vital signs (systolic blood pressure \<90 mmHg or \>140 mmHg, diastolic blood pressure \<50 mmHg or \>90 mmHg) or abnormal physical examination, laboratory examination (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram and other tests with clinical significance;
• Abnormal X-ray examination with clinical significance;
• Hepatitis B surface antigen, hepatitis C antibody and treponema pallidum antibody are positive or HIV antibody is not negative;
• Allergic constitution, including history of severe drug allergy or drug allergy; Allergic history to SHR2554 tablets or the excipients thereof;
• Previous history of cardiovascular diseases such as myocarditis, coronary heart disease, pathological arrhythmia, stroke, etc.;
• Lung diseases, including invasive lung disease, pneumonia, dyspnea, etc.;
• History of chronic kidney disease, renal insufficiency, and renal anemia;
• History of dysphagia or any gastrointestinal disease that affects drug absorption;
• Any uncontrolled peptic ulcer, colitis, pancreatitis, etc.;
• Other important organs of primary diseases, such as the nervous system, cardiovascular system, urinary system, digestive system, respiratory system, metabolism, and clear history of musculoskeletal system including but not limited to tumor patient or a history of cancer, such as not good control of diabetes, high blood pressure, etc.), the researchers think that don't fit for the researchers;
• Patients who had undergone any surgery that would affect drug absorption, distribution, metabolism, or excretion within 3 months prior to screening;
• Took hepatotoxic drugs (e.g. Dapsone, erythromycin, fluconazole, ketoconazole, rifampin) within 6 months before screening;
• Candidates who participated in clinical trials within 3 months before screening;
• Took any drug that alters the activity of liver enzymes within 28 days prior to taking the study drug;
• Took any prescription or over-the-counter medications in the 7 days prior to taking the study drug;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Neoplasms

Study Design

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

Model Details: Randomized, open-label, single-dose, two-cycle, two-sequence, cross-controlled

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: October 24, 2022
• Study Start: November 15, 2022
• Primary Completion: December 14, 2022
• Study Completion: December 14, 2022
• Last Updated: December 19, 2022

Record last verified: 2022-12

Locations

CN (1)