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CompletedNCT05928988Updated Jul 3, 2023

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

A Phase 1 interventional study of SHR8554；Itraconazole in Healthy, sponsored by Jiangsu HengRui Medicine Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.

Sponsored by Jiangsu HengRui Medicine Co., Ltd. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Jan 2022, registered Jun 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
17
Allocation
Not applicable
Ages
18 Years to 45 Years
Sex
All
01

Study 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

02

Conditions studied

  • Healthy
03

In context

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd. is the lead sponsor of 571 studies on the registry; 86 are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 1 (10%) have results posted.

Browse Jiangsu HengRui Medicine Co., Ltd. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
17 participants (actual)

Study arms

  • 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

Interventions

  • DrugSHR8554；Itraconazole

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

06

What researchers measure

Primary outcomes

  1. Cmax：observed maximum plasma concentration

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  2. 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)

  3. 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)

  4. Tmax：observed time to reach Cmax

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  5. Vz ：apparent volume of distribution

    Time frame: Day 1 and Day 9 (pre-dose up to 48 hours post-dose)

  6. 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

  1. Incidence of adverse events (AEs) and serious adverse events (SAEs)

    Time frame: Baseline up to Day 18

  2. Incidence of participants with clinical laboratory abnormalities

    Time frame: Baseline up to Day 18

  3. Incidence of participants with vital signs abnormalities

    Time frame: Baseline up to Day 18

  4. Incidence of participants with physical exam abnormalities

    Time frame: Baseline up to Day 18

07

Study locations

1 site
  • Affiliated Drum Tower Hospital, Medical School of Nanjing University
    Nanjing, Jiangsu 210008, China
08

References and documents

Publications

  • 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. PubMed 40593123 ↗

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 3, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05928988
Lead sponsor
Jiangsu HengRui Medicine Co., Ltd.
Responsible party
Sponsor
First posted
Jul 3, 2023
Start date
Jan 4, 2022
Primary completion
Jan 21, 2022
Completion
Jun 9, 2022
Last update
Jul 3, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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