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Trial Title:
A Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects
NCT ID:
NCT06619873
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Crossover Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-8080
Description:
Medication regimen A
Drug:
600mg, Old process tablets，NPO
Medication regimen B
Drug:
600mg, New process tablets，NPO
Medication regimen C
Drug:
600mg, New process tablets，PC.，low-fat diet
Medication regimen D
Drug:
600mg, New process tablets，PC.，high-fat diet
Arm group label:
Medication regimen A-D-B-C
Arm group label:
Medication regimen B-A-C-D
Arm group label:
Medication regimen C-B-D-A
Arm group label:
Medication regimen D-C-A-B
Summary:
The study is being conducted to evaluate the relative bioavailability of HRS-8080 in the
fasted state in healthy adult subjects and to assess the impact of food on HRS-8080 PK
for the Phase 3 capsule in healthy adult.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Ability to understand the trial procedures and possible adverse events, voluntarily
participate in the trial.
2. Between 18 and 45 years of age, inclusive
3. Female subjects with weight ≥ 45kg, male subjects with weight ≥50kg, body mass index
(BMI) range 19 to 26 kg/m2, inclusive at Screening;
4. Subjects of childbearing potential must agree to take contraceptive measures, and
use requested contraceptive measures with their partners from signing the ICF to 6
months after the last dose. Female subjects must have a negative serum pregnancy
test within 7 days prior to the first dose, be non-lactating, and agree to avoid egg
donation during the treatment period until 6 months after the last dose of the
investigational drug;
Exclusion Criteria:
1. Having a significant history or clinical manifestation of any metabolic, allergic,
dermatological, hepatic, renal, hematological, pulmonary, cardiovascular,
gastrointestinal (GI), neurological, or psychiatric disorder (as determined by the
Investigator);
2. Having a history of epilepsy, including childhood febrile seizures, loss of
consciousness, transient ischemic attack or any condition that may cause seizures,
such as cerebrovascular disease, brain injury, stroke or brain cancer, etc.;
3. History of severe infection within the past 30 days, including but not limited to
bacteremia, severe sepsis, pneumonia requiring hospitalization
4. History of stomach or intestinal surgery (including cholecystectomy) or resection
that would potentially alter absorption and/or excretion of orally administered
drugs except that appendectomy and hernia repair will be allowed;
5. Clinically significant findings from medical history, 12-lead ECG, or vital signs;
6. GFR < 90 ml/min/1.73 m2;
7. Having a QTc interval >470 msec for female and >450 msec for male;
8. Positive hepatitis panel (hepatitis B surface antigen and hepatitis C virus
antibody) or human immunodeficiency virus (HIV) antibody screens;
9. Having a history of significant hypersensitivity, intolerance, or allergy to any
drug compound, food, or other substance, unless approved by the Investigator;
History of allergy to HRS-8080 or any of its excipients;
10. The use or intent to use any medications/products known to alter drug absorption,
metabolism, or elimination processes, including prescription medication, over the
counter medication and traditional Chinese medication, within 30 days prior to
sreening;
11. The participation in any other investigational study drug trial in which receipt of
an investigational study drug occurred within 5 half-lives or 30 days, whichever is
longer, prior to screening;
12. Participated in blood donation within 3 months before screening and donated ≥ 400 mL
of blood or ≥ 400 mL of blood loss; Participated in blood donation within 1 month
before screening and donated blood volume ≥ 200 mL or blood loss ≥ 200 mL; Those who
have received blood transfusions or used blood products within 3 months before
screening;
13. Positive test for selected drugs of abuse at Screening;
14. The use of drugs of abuse (including opioids) within3 months of Screening;
15. having a history of alcoholism or heavy smoker within 3 month prior screening;
unable to abstain from smoking or alcohol during the trial period;
16. Poor peripheral venous access;
17. The need to follow a special diet and unable to consume the high-fat meal;
18. Pregnant or Breastfeeding;
19. In the opinion of the Investigator or Sponsor, are unsuitable for inclusion in the
study;
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
Address:
City:
Hefei
Zip:
230001
Country:
China
Investigator:
Last name:
Zhaoyi Yang
Email:
Principal Investigator
Start date:
October 10, 2024
Completion date:
November 15, 2024
Lead sponsor:
Agency:
Shandong Suncadia Medicine Co., Ltd.
Agency class:
Industry
Source:
Shandong Suncadia Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06619873
