Drug-drug Interaction Study of SPH3127

Drug Drug Interaction Clinical Trial

Official title:

An Open-label, Fixed Sequence Study to Evaluate the Effects of Multi-dose of Itraconazole or Rifampin on the Pharmacokinetic Profiles of Single Dose of SPH3127 in Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05359055
• Other study ID #: SPH3127-104
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: December 13, 2021
• Est. completion date: January 21, 2022

Study information

• Verified date: July 2022
• Source: Shanghai Pharmaceuticals Holding Co., Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single center, open-label, fixed sequence Phase 1, drug-drug interaction (DDI) study in male healthy subjects.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 21, 2022
• Est. primary completion date: January 21, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Willing and able to provide written informed consent;

2. Chinese Male =18 and =45 years;

3. BMI=18.5 and =26.0 kg/m2 and a weight =50.0 kg;

4. Normal or no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the vital signs, physical examination, clinical laboratory tests, and 12-lead ECG.

5. Subjects agreed to have no family planning during the study period and within 6 months after the last study drug administration, voluntarily take effective contraceptive measures and have no sperm donation plan. Non-drug contraceptive measures will be used voluntarily during the trial.

6. Subjects can communicate well with investigators, understand and comply with the requirements of this trial.

Exclusion Criteria:

1. Patients with diseases that need to be excluded, not limited to diseases of the nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal system, respiratory system, metabolism, bone, and other systems;

2. History of allergic diseases;

3. History of dysphagia or any gastrointestinal illness that affects drug absorption;

4. Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug;

5. People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening;

6. Prescribed medications, over-the-counter medications, dietary supplements, or Chinese herbal medicines were taken within 14 days prior to initial administration of the study drug;

7. Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study;

8. Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug.

9. Those who have special dietary requirements and cannot follow a uniform diet;

10. Assessed by the investigators as unsuitable for participating in the study.

Related Conditions & MeSH terms

• Drug Drug Interaction

Intervention

Drug:
• SPH3127 tablet
100mg once daily on Day 1 and Day 8
• Itraconazole
200mg once daily from Day 3 to Day10.
• SPH3127 tablet
200mg once daily on Day 1 and Day 12.
• Rifampin
600mg once daily from Day 3 to Day13.

Locations

Country	Name	City	State
China	West China Second University Hospital, Sichuan University	Chengdu	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Pharmaceuticals Holding Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum serum concentration (Cmax) of SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days
Primary	Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days
Primary	Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days
Secondary	Number of subjects with adverse event.	Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs.	Up to 42 days
Secondary	Time of maximum serum concentration (Tmax) SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days
Secondary	Half-life (t1/2) of SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days
Secondary	Apparent oral clearance (CL/F) of SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days
Secondary	Apparent oral volume of distribution (Vz/F) of SPH3127	To characterize the PK (Pharmacokinetics) of SPH3127	Up to 14 days