A Study to Evaluate the Effect of Itraconazole on Pharmacokinetics (PK) of SHR8554 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: SHR8554；Itraconazole

• Registration Number: NCT05928988
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-04
• Primary Completion: 2022-01-21
• Study Completion: 2022-06-09
• Status Verified: 2023-06
• Study First Submitted: 2023-06-26
• Study First Submitted QC: 2023-06-26
• Last Update Submitted: 2023-06-26
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SHR8554 and itraconazole	SHR8554；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.

Primary Outcome Measures

Name	Time	Method
Cmax：observed maximum plasma 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)
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)
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

Name	Time	Method
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

Trial Locations

Locations (1)

Affiliated Drum Tower Hospital, Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China