Drug-drug Interaction Study of SPH3127

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

Official Title
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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

Conditions
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Drug Drug Interaction

Intervention / Treatment
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* Drug: SPH3127 tablet
* Drug: Itraconazole
* Drug: SPH3127 tablet
* Drug: Rifampin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to provide written informed consent; Chinese Male ≥18 and ≤45 years； BMI≥18.5 and ≤26.0 kg/m2 and a weight ≥50.0 kg; 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. 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. Subjects can communicate well with investigators, understand and comply with the requirements of this trial. Exclusion Criteria: 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; History of allergic diseases; History of dysphagia or any gastrointestinal illness that affects drug absorption; Participated in clinical trials of other investigational drugs within 3 months prior to initial administration of the investigational drug; People who drink excessive tea, coffee and/or caffeinated beverages every day within 3 months before screening; 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; Unwilling to avoid vigorous exercise from 48 hours before the first administration of the study drug to the end of the study; Used of any drug that inhibits or induces hepatic metabolism of the drug in the 28 days prior to taking the study drug. Those who have special dietary requirements and cannot follow a uniform diet; Assessed by the investigators as unsuitable for participating in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>SPH3127 tablet, Itraconazole | Drug: SPH3127 tablet<br>* 100mg once daily on Day 1 and Day 8<br>Drug: Itraconazole<br>* 200mg once daily from Day 3 to Day10.<br>|
| Experimental: Cohort 2<br>SPH3127 tablet, Rifampin | Drug: SPH3127 tablet<br>* 200mg once daily on Day 1 and Day 12.<br>Drug: Rifampin<br>* 600mg once daily from Day 3 to Day13.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum serum concentration (Cmax) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse event. | Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs. | Up to 42 days | 
| Time of maximum serum concentration (Tmax) SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days | 
| Half-life (t1/2) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days | 
| Apparent oral clearance (CL/F) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days | 
| Apparent oral volume of distribution (Vz/F) of SPH3127 | To characterize the PK (Pharmacokinetics) of SPH3127 | Up to 14 days |