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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928988
• Other study ID #: SHR8554-103
• Status: Completed
• Phase: Phase 1
• Start date: January 4, 2022
• Est. completion date: June 9, 2022

Study information

• Verified date: June 2023
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 9, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
China	Affiliated Drum Tower Hospital, Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax:observed maximum plasma concentration		Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Primary	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)
Primary	AUC0-8: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)
Primary	Tmax:observed time to reach Cmax		Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Primary	Vz :apparent volume of distribution		Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Primary	MRT0-8:mean residence time from time 0 to infinity		Day 1 and Day 9 (pre-dose up to 48 hours post-dose)
Secondary	Incidence of adverse events (AEs) and serious adverse events (SAEs)		Baseline up to Day 18
Secondary	Incidence of participants with clinical laboratory abnormalities		Baseline up to Day 18
Secondary	Incidence of participants with vital signs abnormalities		Baseline up to Day 18
Secondary	Incidence of participants with physical exam abnormalities		Baseline up to Day 18