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

NCT06157918 | Completed Phase 1

• 1 other identifier: SYHA1814-003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Tmax

  Up to 120 hours post-dose for eachperiod

• T1/2

  Up to 120 hours post-dose for eachperiod

• Title:Cl/F

  Up to 120 hours post-dose for eachperiod

• V/F

  Up to 120 hours post-dose for eachperiod

• Number of participants with Adverse Events

  Up to 34 days

Study Arms (3)

Group 1-sequence ABC

EXPERIMENTAL

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); Drug: SYHA1813 oral solution (20ml:200mg)

Group 2-sequence BCA

EXPERIMENTAL

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); Drug: SYHA1813 oral solution (20ml:200mg)

Group 3-sequence CAB

EXPERIMENTAL

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); Drug: SYHA1813 oral solution (20ml:200mg)

Interventions

SYHA1813 oral solution (2.0g:25mg) DRUG

SYHA1813 oral solution, 25mg, oral

Group 1-sequence ABC; Group 2-sequence BCA; Group 3-sequence CAB

SYHA1813 oral solution (20ml:200mg) DRUG

SYHA1813 oral solution, 25mg, oral

Group 1-sequence ABC; Group 2-sequence BCA; Group 3-sequence CAB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male aged 18 to 60 years old;
• Weight more than 50.0 kg and body mass index between 19 to 26.0 kg/m\^2;
• 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;
• 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;
• Voluntarily sign the informed consent form, and cooperate in completing the trial according to the protocol.

You may not qualify if:

• Allergic constitution (allergic to 2 or more kinds of drugs, food, or pollen);
• 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;
• 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;
• Participants who have undergone major surgery within 6 months prior to screening or who are scheduled to undergo surgery during the trial;
• Participants with 1 or more abnormal vital signs at screening;
• Abnormal and clinically significant electrocardiograms: QTc interval \>450ms;
• 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;
• Smoking ≥ 5 cigarettes per day on average within 6 months prior to screening;
• Participants with a history of drug or substance abuse, or a positive urine drug screen;
• 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;
• Participants who have participated in other clinical trials within 3 months prior to screening;
• 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;
• 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;
• Participants who have used potent inhibitors or inducers of CYP enzymes (e.g., CYP2C9, 2C19, and 3A4) within 4 weeks prior to screening;
• 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;

Sponsors & Collaborators

• Shanghai Runshi Pharmaceutical Technology Co., Ltd: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Shanghai, China

Location

Study Design

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

Model Details: 3-period Crossover Assignment

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: December 20, 2023
• Primary Completion: January 26, 2024
• Study Completion: January 26, 2024
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)