Clinical trial NCT05928988: A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-07-03
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

1. Healthy male and female subjects, aged 18 to 45 years (inclusive).
2. 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).
3. Understand the study procedures in the informed consent form and be willing and able to comply with the protocol.

Exclusion Criteria:

1. Subjects with a history of drug allergy, or a history of specific allergies, or known allergy to SHR8554 or itraconazole or similar.
2. 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.
3. Subjects with positive tests for infectious diseases.
4. 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.
5. History of using any medication within 2 weeks prior to the first dosing.
6. Subjects who have received vaccination within 1 month prior to screening or plan to receive vaccination during the trial.
7. Excessive daily consumption of tea, coffee, grapefruit/grapefruit juice and other special diets in the 1 month prior to screening.
8. Subjects with a history of substance abuse, drug use or a positive screening test for substance abuse.
9. Female who are pregnant or breastfeeding, or have a positive pregnancy test.
10. Subjects who may not be able to complete the study for other reasons or who the investigator believes should not be included.

Primary outcomes:
measure: Cmax：observed maximum plasma concentration
timeFrame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
measure: AUC0-t ：area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration
timeFrame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
measure: AUC0-∞：area under the plasma concentration-time curve from time 0 to infinity
timeFrame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
measure: Tmax：observed time to reach Cmax
timeFrame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
measure: Vz ：apparent volume of distribution
timeFrame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
measure: MRT0-∞：mean residence time from time 0 to infinity
timeFrame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Secondary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline up to Day 18
measure: Incidence of participants with clinical laboratory abnormalities
timeFrame: Baseline up to Day 18
measure: Incidence of participants with vital signs abnormalities
timeFrame: Baseline up to Day 18
measure: Incidence of participants with physical exam abnormalities
timeFrame: Baseline up to Day 18
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Affiliated Drum Tower Hospital, Medical School of Nanjing University
state: Jiangsu
Study officials:
References: