Drug-drug Interaction Study of SPH3127

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

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

Study Overview

• Status: Completed
• Conditions: Drug Drug Interaction
• Intervention / Treatment: Drug: SPH3127 tablet; Drug: Itraconazole; Drug: SPH3127 tablet; Drug: Rifampin

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610044
      • West China Second University Hospital, Sichuan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd
• Investigators: Principal Investigator: Qin Yu, West China Second University Hospital, Sichuan University

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2021
• Primary Completion (Actual): January 21, 2022
• Study Completion (Actual): January 21, 2022

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): July 29, 2022
• Last Update Submitted That Met QC Criteria: July 28, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Nucleic Acid Synthesis Inhibitors; Enzyme Inhibitors; Hormones, Hormone Substitutes, and Hormone Antagonists; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Leprostatic Agents; Hormone Antagonists; Cytochrome P-450 Enzyme Inducers; Antifungal Agents; Steroid Synthesis Inhibitors; Cytochrome P-450 CYP3A Inducers; Antitubercular Agents; 14-alpha Demethylase Inhibitors; Antibiotics, Antitubercular; Cytochrome P-450 CYP2B6 Inducers; Cytochrome P-450 CYP2C8 Inducers; Cytochrome P-450 CYP2C19 Inducers; Cytochrome P-450 CYP2C9 Inducers; Rifampin; Itraconazole
• Other Study ID Numbers: SPH3127-104

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No