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

Healthy Participants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157918
• Other study ID #: SYHA1814-003
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: December 12, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: November 2023
• Source: Shanghai Runshi Pharmaceutical Technology Co., Ltd
• Contact: Clinical Trials Information Group
• Phone: +86-0311-69085587
• Email: ctr-contact[@]mail.ecspc.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 18
• Est. completion date: February 28, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• SYHA1813 oral solution (2.0g:25mg)
SYHA1813 oral solution, 25mg, oral
• SYHA1813 oral solution (20ml:200mg)
SYHA1813 oral solution, 25mg, oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Runshi Pharmaceutical Technology Co., Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum observed plasma concentration	Up to 120 hours post-dose for eachperiod
Primary	AUC0-8	Area under the plasma concentration time curve from time zero extrapolated to infinite time	Up to 120 hours post-dose for eachperiod
Primary	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	Tmax	Time of maximum observed plasma concentration	Up to 120 hours post-dose for eachperiod
Secondary	T1/2	Terminal elimination half-life	Up to 120 hours post-dose for eachperiod
Secondary	Title:Cl/F	Apparent total body clearance	Up to 120 hours post-dose for eachperiod
Secondary	V/F	Apparent volume of distribution	Up to 120 hours post-dose for eachperiod
Secondary	Number of participants with Adverse Events		Up to 34 days