Clinical trial NCT06619873: A Phase 1, Randomized, Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects
Official title: A Phase 1, Open-Label, Single-Dose, Randomized, Four-Period Crossover Study to Evaluate the Relative Bioavailability and Food Effect of HRS-8080 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Breast Cancer
Lead sponsor: Shandong Suncadia Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-01
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


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;

Primary outcomes:
measure: Cmax
timeFrame: 0 hour-48 hour
measure: AUC0-t
timeFrame: 0 hour-48 hour
measure: AUC0-inf
timeFrame: 0 hour-48 hour
Secondary outcomes:
measure: Tmax
timeFrame: 0 hour-48 hour
measure: T1/2
timeFrame: 0 hour-48 hour
measure: CL/F
timeFrame: 0 hour-48 hour
measure: Vz/F
timeFrame: 0 hour-48 hour
Other outcomes:
Locations:
city: Hefei
country: China
facility: The Frist Affiliated Hospital of USTC (Anhui Provincial Hospital)
state: Anhui
Study officials:
References: