A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects
Study Details
Study Description
Brief Summary
This drug-drug interaction (DDI) study has been designed to characterize the pharmacokinetic profile of SHR8554 when co administered with a strong cytochrome P450 3A4 (CYP3A4) inhibitor itraconazole
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SHR8554 and itraconazole SHR8554 will be provided in a solution. Participants will receive 1 mg SHR8554 by intravenous pump on Day 1 and Day 9. Itraconazole capsules 200 mg orally after meals twice daily for 7 days from Day 4 to Day 10. |
Drug: SHR8554；Itraconazole
Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm
|
Outcome Measures
Primary Outcome Measures
- Cmax：observed maximum plasma concentration [Day 1 and Day 9 (pre-dose up to 48 hours post-dose)]
- AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration [Day 1 and Day 9 (pre-dose up to 48 hours post-dose)]
- AUC0-∞：area under the plasma concentration-time curve from time 0 to infinity [Day 1 and Day 9 (pre-dose up to 48 hours post-dose)]
- Tmax：observed time to reach Cmax [Day 1 and Day 9 (pre-dose up to 48 hours post-dose)]
- Vz ：apparent volume of distribution [Day 1 and Day 9 (pre-dose up to 48 hours post-dose)]
- MRT0-∞：mean residence time from time 0 to infinity [Day 1 and Day 9 (pre-dose up to 48 hours post-dose)]
Secondary Outcome Measures
- Incidence of adverse events (AEs) and serious adverse events (SAEs) [Baseline up to Day 18]
- Incidence of participants with clinical laboratory abnormalities [Baseline up to Day 18]
- Incidence of participants with vital signs abnormalities [Baseline up to Day 18]
- Incidence of participants with physical exam abnormalities [Baseline up to Day 18]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Healthy male and female subjects, aged 18 to 45 years (inclusive).
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Female subjects body weight≥45 kg, male subjects body weight≥50 kg, body mass index (BMI) of 19.0 to 26.0 kg/m2 (inclusive).
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Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.
Exclusion Criteria:
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Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
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Any condition or disease detected during the medical interview/physical examination that would render the participant unsuitable for the study as determined by the investigator.
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Subjects with positive tests for infectious diseases.
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Subjects who have undergone major surgery within 3 months prior to screening or have undergone surgery that could significantly affect the in vivo course or safety evaluation of the study drug.
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History of using any medication within 2 weeks prior to the first dosing.
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Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
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Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
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Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
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Female who are pregnant or breastfeeding, or have a positive pregnancy test.
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Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Affiliated Drum Tower Hospital, Medical School of Nanjing University | Nanjing | Jiangsu | China | 210008 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR8554-103