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

NCT05928988 | Completed Phase 1

• 1 other identifier: SHR8554-103
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (4)

• 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

Study Arms (1)

SHR8554 and itraconazole

EXPERIMENTAL

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

Interventions

SHR8554；Itraconazole DRUG

Drug: SHR8554 Administered as specified in the treatment arm Drug: Itraconazole Administered as specified in the treatment arm

SHR8554 and itraconazole

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Affiliated Drum Tower Hospital, Medical School of Nanjing University

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• Huang L, Jiang H, Huang Y, Li J. Exploring Pharmacokinetic interactions between SHR8554, a micro-opioid receptor biased agonist, and Itraconazole in healthy Chinese subjects. Sci Rep. 2025 Jul 2;15(1):22635. doi: 10.1038/s41598-025-98697-3.

  PMID: 40593123 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2023
• First Posted: July 3, 2023
• Study Start: January 4, 2022
• Primary Completion: January 21, 2022
• Study Completion: June 9, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

CN (1)