Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules

Healthy Subjects Clinical Trial

Official title:

Safety and Pharmacokinetics Study of Multiple Ascending Doses and Food Effect of LV232 Capsules in Chinese Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06279533
• Other study ID #: LV232-02
• Status: Recruiting
• Phase: Phase 1
• Start date: February 27, 2024
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: Vigonvita Life Sciences
• Contact: Huaqing Duan
• Phone: +86-18061926005
• Email: huaqing.duan[@]vigonvita.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is divided into two parts: the safety, tolerability, pharmacokinetic profiles of LV232 capsules after multiple ascending doses (hereinafter referred to as "PK characteristics of multiple ascending doses study ") and food effect study (hereinafter referred to as "FE study"). A total of 48 subjects are planned to be enrolled. The two parts of the study can be carried out simultaneously, and there is no order requirement.

Description:

PK characteristics of multiple ascending doses study is used randomized, double-blinded, placebo-controlled, single-center design. LV232/Placebo is administered sequentially from low-dose to high-dose and each subject can only orally receive one dose level. There are 3 dose groups (15mg, 25mg and 40mg), 8 subjects will be enrolled in each dose group and the ratio of investigational product to placebo is 3:1. Investigational product is orally administrated QD for day1, day3~day9. When 7th day visit after last dose (D15) is completed for previous dose group, investigator and sponsor will evaluate the safety and determine whether the next dose group can be started or adjusted.

FE study is a single-center, randomized, open-label, three-period crossover design. 24 healthy subjects divided into 2 groups will be enrolled once all eligibility criteria are met after screening within 14 days prior to investigation product administration. Informed consent should be obtained before any protocol defined procedures can be started.Investigational product administration plan given below: 12 healthy subjects in each group will be randomized to 3 sub-groups, i.e., Group A, Group B, Group C, with 4 subjects in each sub-group. For group A, investigation product will be given after fasting for Period 1, after standard diet for Period 2, and after high-fat diet for Period 3; For group B, investigation product will be given after high-fat diet for Period 1, after fasting for Period 2, and after standard diet for Period 3; For group C, investigation product will be given after standard diet for Period 1, after high-fat diet for Period 2, and after fasting for Period 3. There are 2 dose groups (25mg and 40mg) and wash-out period is 5 days.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Aged 18 to 45 years old, males or females;

2. Body weight no less than 50.0 kg for male, no less than 45.0 kg for female,Body Mass Index of 19.0 to 26.0kg/m2;

3. Physical examination, vital signs examination, laboratory examination, electrocardiogram examination and B-ultrasound examination results were normal or abnormal without clinical significant;

4. Subjects who are willing to take effective contraceptive during the study and within 3 months after the study completed;

5. Subjects who are able to understand and follow study plans and instructions; Subjects who have voluntarily decided to participate in this study, and signed the informed consent form.

Exclusion Criteria:

1. Subjects with hypersensitivity to LV232 or any of the excipients;

2. Subjects with allergic diseases or allergic constitution;

3. Subjects with skin diseases or a history of skin allergies;

4. Subjects with central nervous system, cardiovascular system, gastrointestinal, respiratory system, urinary, Hematologic System, metabolic disorders that require medical intervention or other diseases (such as psychiatric history) that are not suitable for clinical trials;

5. Blood donation or blood loss = 400 mL within 3 months , or have a history of blood product use history

6. Subjects who have participated in clinical trials of other drugs within 3 months before screening;

7. Subjects who have taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health products orally within 2 weeks before screening;

8. Drug or alcohol addicts within 1 year prior to screening, who drink at least twice a day or more than 14 units per week, or who are addicted to alcohol (1 unit ˜200 mL beer with 5% alcohol content, 25 mL spirits with 40% alcohol content or 85 mL wine with 12% alcohol content);

9. Subjects who smoked more than 10 cigarettes or equivalent amounts of tobacco a day within one year before screening;

10. Subjects who can't quit smoking and drinking during the experiment;

11. Subjects who are positive for hepatitis B virus surface antigen, hepatitis C virus antibody, Treponema pallidum antibody (TPPA) or human immunodeficiency virus antibody (Anti-HIV);

12. Abnormal and clinically significant chest radiographs (anteroposterior);

13. B ultrasound examination showed moderate to severe fatty liver;

14. Pregnant or lactating woman or male subjects whose spouse has a child care plan within 3 months;

15. The investigator believes that there are other factors that are not suitable for participating in this trial.

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• LV232/Placebo
Drug: LV232 15mg Group: 6 subjects will receive LV232 15mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally. Drug: LV232 25mg Group: 6 subjects will receive LV232 25mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally. Drug: LV232 40mg Group: 6 subjects will receive LV232 40mg, orally; Other Names:Placebo 2 subjects will receive placebo, orally.
• LV232
Drug: LV232 15mg Group: 12 subjects will receive LV232 15mg, orally Drug: LV232 25mg Group: 12 subjects will receive LV232 25mg, orally

Locations

Country	Name	City	State
China	Shanghai Xuhui Central Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Vigonvita Life Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tmax	Maximum observed plasma concentration	Calculated using concentration data collected from predose to 72 hours postdose
Primary	Cmax	Maximum observed plasma concentration	Calculated using concentration data collected from predose to 72 hours postdose
Primary	T1/2	Terminal half life	Calculated using concentration data collected from predose to 72 hours postdose
Primary	AUC0-t	Area under the serum concentration time profile from time zero to the time of the last quantifiable concentration	Calculated using concentration data collected from predose to 72 hours postdose
Primary	AUC0-24h	Area under the serum concentration time profile from time zero to the time of 24h	Calculated using concentration data collected from predose to 24 hours postdose
Primary	AUC0-8	Area under the plasma concentration-time curve from time 0 extrapolated to infinity	Calculated using concentration data collected from predose to 72 hours postdose
Secondary	Number of participants with treatment emergent treatment-related adverse event(s)	Frequency, severity and causal relationship of treatment emergent adverse events	Dosing through follow-up call (7 days after last dose of investigational product)
Secondary	Laboratory test	Number of participants with laboratory test findings of potential clinical importance	Dosing through follow-up call (7 days after last dose of investigational product)
Secondary	Vital signs	Number of participants with vital signs findings of potential clinical importance	Dosing through follow-up call (7 days after last dose of investigational product)
Secondary	Number of participants with ECG findings of potential clinical importance	Number of subjects with change from baseline in electrocardiogram (ECG) parameters	Dosing through follow-up call (7 days after last dose of investigational product)