Clinical trial · Interventional
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
NCT07229560CI-TRIAL-00100814completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HRS-8080 Tablet | Drug | — | UNRESOLVED |
| Itraconazole Capsule | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HRS-8080 Tablets and Itraconazole Capsules Group
- interventionNames
- Drug: HRS-8080 Tablet
- Drug: Itraconazole Capsule
Primary outcomes (3)
- measure
- Maximum concentration (Cmax) of HRS-8080.
- timeFrame
- From Day 1 to Day 11.
- measure
- Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUClast) of HRS-8080.
- timeFrame
- From Day 1 to Day 11.
- measure
- Area under the plasma concentration-time curve from time zero to infinity (AUCinf) of HRS-8080.
- timeFrame
- From Day 1 to Day 11.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.