Relative Bioavailability and Food Effect of SYHA1813 Oral Solution in Healthy Participants

A Single-Center, Randomized, Open-label, Single-dose, 3-Sequence, 3-Period Rossover Design to Evaluate the Relative Bioavailability and Food Effect of SYHA1813 Oral Solution in Healthy Participants

This is a three-period crossover phase I study designed to evaluate the relative bioavailability, food effect, safety and tolerability of SYHA1813 oral solution in healthy participants.

Study Overview

• Status: Completed
• Conditions: Healthy Participants
• Intervention / Treatment: Drug: SYHA1813 oral solution (2.0g:25mg); Drug: SYHA1813 oral solution (20ml:200mg)

Detailed Description

Avoid duplicating information that will be entered elsewhere, such as Eligibility Criteria or Outcome Measures.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Healthy male aged 18 to 60 years old;
2. Weight more than 50.0 kg and body mass index between 19 to 26.0 kg/m^2;
3. Normal or abnormal results without clinical significance on all tests including medical history, vital signs, physical examination, laboratory evaluation (routine blood, blood biochemistry, urine routine, coagulation function, serum virology, and other related tests), 12-lead electrocardiogram, chest X-ray and other tests;
4. Male participants and their partners must agree to use effective non-hormonal contraception from the first administration of the test drug to 6 months after the last administration of the test drug, even if permanent contraception has already been used, and the male participant does not plan to donate sperm;
5. Voluntarily sign the informed consent form, and cooperate in completing the trial according to the protocol.

Exclusion Criteria:

1. Allergic constitution (allergic to 2 or more kinds of drugs, food, or pollen);
2. Participants with a clear history of neurological disease or psychiatric disease, a history of severe cardiovascular, hepatic, renal, endocrine, respiratory, hematologic, digestive, immune, and other various systemic diseases, or a history of malignant neoplastic disease;
3. Participants who are unable to swallow orally administered drugs, or clinically significant abnormalities in gastrointestinal function that could affect drug absorption, distribution, metabolism, and excretion;
4. Participants who have undergone major surgery within 6 months prior to screening or who are scheduled to undergo surgery during the trial;
5. Participants with 1 or more abnormal vital signs at screening;
6. Abnormal and clinically significant electrocardiograms: QTc interval >450ms;
7. Participants who consumed more than 14 units of alcohol per week in the 4 weeks prior to screening or who had a positive breath test for alcohol at screening;
8. Smoking ≥ 5 cigarettes per day on average within 6 months prior to screening;
9. Participants with a history of drug or substance abuse, or a positive urine drug screen;
10. Participants who have lost blood or donated more than 400 ml of blood within 4 weeks prior to screening or plan to donate blood during the study or within 1 month of the end of the study;
11. Participants who have participated in other clinical trials within 3 months prior to screening;
12. Habitual intake of excessive xanthine or caffeine-containing foods, beverages, or other foods that interfere with drug absorption, distribution, metabolism, excretion within 4 weeks prior to screening;
13. Participants who have taken a special diet (dragon fruit, mango, grapefruit, lime, poppy seed, or food or drink prepared from them) within 7 days prior to screening, or participants who are unable to stop taking the above special diets during the trial;
14. Participants who have used potent inhibitors or inducers of CYP enzymes (e.g., CYP2C9, 2C19, and 3A4) within 4 weeks prior to screening;
15. Participants who have used prescription, over-the-counter, herbal, vitamin, or mineral medications within 2 weeks prior to screening, and participants who have taken medications prior to screening that have not completed 5 half-lives, whichever is longer among the various medications;
16. Participants who cannot tolerate venipuncture or with a history of fainting needle or blood;
17. Participants who are lactose intolerant;
18. Any condition that the investigator considers inappropriate for participation in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1-sequence ABC; Participants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), followed by SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), and SYHA1813 oral solution (2.0g:25mg) fed (Treatment C).	Drug: SYHA1813 oral solution (2.0g:25mg); SYHA1813 oral solution, 25mg, oral; Drug: SYHA1813 oral solution (20ml:200mg); SYHA1813 oral solution, 25mg, oral
Experimental: Group 2-sequence BCA; Participants will sequentially receive SYHA1813 oral solution (20ml:200mg) fasted (Treatment B), followed by SYHA1813 oral solution (2.0g:25mg) fed(Treatment C), and SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A).	Drug: SYHA1813 oral solution (2.0g:25mg); SYHA1813 oral solution, 25mg, oral; Drug: SYHA1813 oral solution (20ml:200mg); SYHA1813 oral solution, 25mg, oral
Experimental: Group 3-sequence CAB; Participants will sequentially receive SYHA1813 oral solution (2.0g:25mg) fed (Treatment C), followed by SYHA1813 oral solution (2.0g:25mg) fasted (Treatment A), and SYHA1813 oral solution (20ml:200mg) fasted (Treatment B).	Drug: SYHA1813 oral solution (2.0g:25mg); SYHA1813 oral solution, 25mg, oral; Drug: SYHA1813 oral solution (20ml:200mg); SYHA1813 oral solution, 25mg, oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum observed plasma concentration	Up to 120 hours post-dose for eachperiod
AUC0-∞	Area under the plasma concentration time curve from time zero extrapolated to infinite time	Up to 120 hours post-dose for eachperiod
AUC0-t	Area under the plasma concentration time curve from time zero to the time of the last quantifiable concentration	Up to 120 hours post-dose for eachperiod

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tmax	Time of maximum observed plasma concentration	Up to 120 hours post-dose for eachperiod
T1/2	Terminal elimination half-life	Up to 120 hours post-dose for eachperiod
Title:Cl/F	Apparent total body clearance	Up to 120 hours post-dose for eachperiod
V/F	Apparent volume of distribution	Up to 120 hours post-dose for eachperiod
Number of participants with Adverse Events		Up to 34 days

Collaborators and Investigators

• Sponsor: Shanghai Runshi Pharmaceutical Technology Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2023
• Primary Completion (Actual): January 26, 2024
• Study Completion (Actual): January 26, 2024

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 7, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions
• Other Study ID Numbers: SYHA1814-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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