Clinical trial NCT05359055: Drug-drug Interaction Study of SPH3127
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Drug Drug Interaction
Lead sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
Sponsor class: INDUSTRY
First posted: 2022-05-03
Enrollment: 40
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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.

Primary outcomes:
measure: Maximum serum concentration (Cmax) of SPH3127
timeFrame: Up to 14 days
measure: Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-Last) of SPH3127
timeFrame: Up to 14 days
measure: Area under the serum concentration-time curve (AUC) of the Dosing Interval (0-infinity) of SPH3127
timeFrame: Up to 14 days
Secondary outcomes:
measure: Number of subjects with adverse event.
timeFrame: Up to 42 days
measure: Time of maximum serum concentration (Tmax) SPH3127
timeFrame: Up to 14 days
measure: Half-life (t1/2) of SPH3127
timeFrame: Up to 14 days
measure: Apparent oral clearance (CL/F) of SPH3127
timeFrame: Up to 14 days
measure: Apparent oral volume of distribution (Vz/F) of SPH3127
timeFrame: Up to 14 days
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Second University Hospital, Sichuan University
state: Sichuan
Study officials:
affiliation: West China Second University Hospital
name: Qin Yu
role: PRINCIPAL_INVESTIGATOR
References: