Drug-drug Interaction Study of SPH3127

• Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05359055
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Actual Duration (Months): 1.3
• Patients Per Site Per Month: 31.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Drug Drug Interaction	Drug: SPH3127 tablet; Drug: Itraconazole; Drug: SPH3127 tablet; Drug: Rifampin	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Dec 13, 2021
• Actual Primary Completion Date: Jan 21, 2022
• Actual Study Completion Date: Jan 21, 2022

Arms and Interventions

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.
Experimental: Cohort 2 SPH3127 tablet, Rifampin	Drug: SPH3127 tablet; 200mg once daily on Day 1 and Day 12.; Drug: Rifampin; 600mg once daily from Day 3 to Day13.

Outcome Measures

Primary Outcome Measures

1. Maximum serum concentration (Cmax) of SPH3127 [Up to 14 days]

   To characterize the PK (Pharmacokinetics) of SPH3127

2. 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

3. 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

1. Number of subjects with adverse event. [Up to 42 days]

   Adverse events, 12-lead ECG, clinical laboratory tests, physical examination and vital signs.

2. Time of maximum serum concentration (Tmax) SPH3127 [Up to 14 days]

   To characterize the PK (Pharmacokinetics) of SPH3127

3. Half-life (t1/2) of SPH3127 [Up to 14 days]

   To characterize the PK (Pharmacokinetics) of SPH3127

4. Apparent oral clearance (CL/F) of SPH3127 [Up to 14 days]

   To characterize the PK (Pharmacokinetics) of SPH3127

5. Apparent oral volume of distribution (Vz/F) of SPH3127 [Up to 14 days]

   To characterize the PK (Pharmacokinetics) of SPH3127

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	West China Second University Hospital, Sichuan University	Chengdu	Sichuan	China	610044

Sponsors and Collaborators

• Shanghai Pharmaceuticals Holding Co., Ltd

Investigators

• Principal Investigator: Qin Yu, West China Second University Hospital, Sichuan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Pharmaceuticals Holding Co., Ltd
• ClinicalTrials.gov Identifier: NCT05359055
• Other Study ID Numbers: SPH3127-104
• First Posted: May 3, 2022
• Last Update Posted: Jul 29, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Itraconazole; Rifampin

Study Results

No Results Posted as of Jul 29, 2022