A Trial of Itraconazole Effect on HRS-8080 Pharmacokinetics in Healthy Participants

The Effect of Itraconazole on the Pharmacokinetics of Orally Administered HRS-8080 in Healthy Participants: A Single-Center, Single-Arm, Open-Label, Fixed-Sequence Study

This is a phase I study to evaluate the effect of Itraconazole on the pharmacokinetics of HRS-8080 in healthy participants and the safety of HRS-8080 administered alone and in combination with Itraconazole in healthy participants.

Inclusion Criteria:

1. Aged 18-55 years;
2. Male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (BMI): 19-28 kg/m2;
3. Normal or no clinically significant medical history, ECGs, vital signs and laboratory tests;
4. Take contraception.

Exclusion Criteria:

1. Any serious clinical diseases or medical history or diseases that affect the absorption, metabolism and/or excretion of the study drug;
2. Severe infection, severe trauma or major surgery;
3. Any medications in the two weeks before screening or baseline period;
4. History of blood donation or severe blood loss;
5. Have been vaccinated within 3 months before the screening or baseline period;
6. History of smoking or excessive alcohol or drug abuse;
7. History of excessive amounts of tea, coffee or caffeinated beverages, special foods; or have special dietary requirements;
8. Other situations in which the researcher judges unsuitable.