Drug-drug Interaction Study of SPH3127

NCT05359055 | Completed Phase 1

• 1 other identifier: SPH3127-104
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Drug Drug Interaction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of subjects with adverse event.

  Up to 42 days

• Time of maximum serum concentration (Tmax) SPH3127

  Up to 14 days

• Half-life (t1/2) of SPH3127

  Up to 14 days

• Apparent oral clearance (CL/F) of SPH3127

  Up to 14 days

• Apparent oral volume of distribution (Vz/F) of SPH3127

  Up to 14 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

SPH3127 tablet, Itraconazole

Drug: SPH3127 tablet; Drug: Itraconazole

Cohort 2

EXPERIMENTAL

SPH3127 tablet, Rifampin

Drug: SPH3127 tablet; Drug: Rifampin

Interventions

SPH3127 tablet DRUG

100mg once daily on Day 1 and Day 8

Cohort 1

Itraconazole DRUG

200mg once daily from Day 3 to Day10.

Cohort 1

Rifampin DRUG

600mg once daily from Day 3 to Day13.

Cohort 2

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd: lead

Study Sites (1)

West China Second University Hospital, Sichuan University

Chengdu, Sichuan, 610044, China

Location

MeSH Terms

Interventions

SPH3127; Itraconazole; Rifampin

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Qin Yu

  West China Second University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: December 13, 2021
• Primary Completion: January 21, 2022
• Study Completion: January 21, 2022
• Last Updated: July 29, 2022

Record last verified: 2022-07

Locations

CN (1)