Drug-drug Interaction Study of SPH3127

Phase 1

Completed

• Conditions: Drug Drug Interaction
• Interventions: Drug: SPH3127 tablet; Drug: Itraconazole; Drug: Rifampin

• Registration Number: NCT05359055
• Lead Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-13
• Primary Completion: 2022-01-21
• Study Completion: 2022-01-21
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-05-03
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-28
• Last Update Posted: 2022-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1	SPH3127 tablet	SPH3127 tablet, Itraconazole
Cohort 1	Itraconazole	SPH3127 tablet, Itraconazole
Cohort 2	SPH3127 tablet	SPH3127 tablet, Rifampin
Cohort 2	Rifampin	SPH3127 tablet, Rifampin

Primary Outcome Measures

Name	Time	Method
Maximum serum concentration (Cmax) of SPH3127	Up to 14 days	To characterize the PK (Pharmacokinetics) of SPH3127
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127	Up to 14 days	To characterize the PK (Pharmacokinetics) of SPH3127
Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127	Up to 14 days	To characterize the PK (Pharmacokinetics) of SPH3127

Secondary Outcome Measures

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

Trial Locations

Locations (1)

West China Second University Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China