A Phase 1, Open-label, Fixed-sequence Study to Estimate the Effects of Multiple-dose Administration of Itraconazole on the Pharmacokinetics of SHR8554 in Healthy Adult Subjects
Overview
- Phase
- Phase 1
- Intervention
- SHR8554；Itraconazole
- Conditions
- Healthy
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- Tmax：observed time to reach Cmax
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male and female subjects, aged 18 to 45 years (inclusive).
- •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).
- •Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.
Exclusion Criteria
- •Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
- •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.
- •Subjects with positive tests for infectious diseases.
- •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.
- •History of using any medication within 2 weeks prior to the first dosing.
- •Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
- •Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
- •Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
- •Female who are pregnant or breastfeeding, or have a positive pregnancy test.
- •Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.
Arms & Interventions
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.
Intervention: SHR8554；Itraconazole
Outcomes
Primary Outcomes
Tmax：observed time to reach Cmax
Time Frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Cmax：observed maximum plasma concentration
Time Frame: 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
Time Frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Vz ：apparent volume of distribution
Time Frame: 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
Time Frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
MRT0-∞：mean residence time from time 0 to infinity
Time Frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Secondary Outcomes
- 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)