Clinical trial · Interventional
A Phase 1 Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects
A Single-center, Single-arm, Open-label, Fixed-sequence, Self-controlled Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of SHR7280 and Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects
NCT06949124CI-TRIAL-00094837completedPhase 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)
The purpose of this study is to evaluate the effects of SHR7280 on the pharmacokinetics of midazolam, S-warfarin, omeprazole, digoxin and rosuvastatin in healthy subjects.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Assisted Reproduction | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SHR7280 Tablets | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group
- interventionNames
- Drug: SHR7280 Tablets
Primary outcomes (3)
- measure
- Maximum concentration (Cmax)
- timeFrame
- 0 to anticipated 29 days.
- measure
- Area under the curve from time 0 to infinity (AUC0-∞)
- timeFrame
- 0 to anticipated 29 days.
- measure
- Area under the curve from time 0 to time t (AUC0-t)
- timeFrame
- 0 to anticipated 29 days.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 45 Years
Show eligibility criteria text
Inclusion Criteria: 1. Voluntarily sign the informed consent form prior to any study-related activities, understand the procedures and methods of the study, and agree to complete this study in strict accordance with the clinical study protocol. 2. Males aged 18-45 years (inclusive). 3. Subjects who are generally healthy as judged by the investigator based on medical history, vital signs, physical examination, laboratory tests, and electrocardiogram (ECG). 4. Weight ≥ 50 kg and body mass index (BMI) : 19-26 kg/m2 (inclusive). 5. Informed consent was obtained and patients did not plan to have children within 3 months after the last dose of medication, and they agreed to use highly effective contraception. Exclusion Criteria: 1. Those with clinically significant abnormalities in physical examination, vital signs (respiration, temperature, pulse), other laboratory tests, chest imaging, abdominal ultrasound, etc. 2. Hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody and syphilis antibody positive. 3. Patients with any previous diseases that increase the risk of bleeding. 4. Patients with previous chronic or severe medical history or existing diseases of the respiratory system, circulatory system, digestive system, urinary system, blood system, endocrine system, immune system, nervous system, and mental system, who were judged by the investigators to be not suitable for the trial. 5. History of blood donation or blood loss ≥ 400 mL or blood transfusion within 3 month before screening. 6. Subjects with other factors considered by the investigator to be ineligible for the study.
References
Publications (0)
Data not yet available
No reference posted for this study.