Drug-drug Interaction Study of SPH3127

NCT ID: NCT05359055

Last Updated: 2022-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2022-01-21

Brief Summary

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

Conditions

Drug Drug Interaction

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

SPH3127 tablet, Itraconazole

Group Type: EXPERIMENTAL

SPH3127 tablet

Intervention Type: DRUG

100mg once daily on Day 1 and Day 8

Itraconazole

Intervention Type: DRUG

200mg once daily from Day 3 to Day10.

Cohort 2

SPH3127 tablet, Rifampin

Group Type: EXPERIMENTAL

SPH3127 tablet

Intervention Type: DRUG

200mg once daily on Day 1 and Day 12.

Rifampin

Intervention Type: DRUG

600mg once daily from Day 3 to Day13.

Interventions

SPH3127 tablet

100mg once daily on Day 1 and Day 8

Intervention Type: DRUG

Itraconazole

200mg once daily from Day 3 to Day10.

Intervention Type: DRUG

SPH3127 tablet

200mg once daily on Day 1 and Day 12.

Intervention Type: DRUG

Rifampin

600mg once daily from Day 3 to Day13.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Shanghai Pharmaceuticals Holding Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qin Yu

Role: PRINCIPAL_INVESTIGATOR

West China Second University Hospital

Locations

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, China

Countries

China

Other Identifiers

SPH3127-104

Identifier Type: -

Identifier Source: org_study_id