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

Shandong Suncadia Medicine

Status and phase: Completed; Phase 1

Conditions: Breast Cancer

Treatments: Drug: HRS-8080 Tablet; Drug: Itraconazole Capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT07229560

HRS-8080-105

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

HRS-8080 Tablets and Itraconazole Capsules Group

Experimental group

Treatment:

Drug: Itraconazole Capsule

Drug: HRS-8080 Tablet