A Food-Effect Study of AND017 in Healthy Participants

Healthy Volunteers Clinical Trial

Official title:

A Single-Center, Randomized, Open-Label, Two-Sequence, Two-Period Crossover Study in Healthy Non-Elderly Chinese Subjects to Evaluate the Food Effect on the Pharmacokinetics of AND017 Following Oral Single-Dose Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04712500
• Other study ID #: AND017-CN-101
• Status: Completed
• Phase: Phase 1
• Start date: July 30, 2020
• Est. completion date: August 21, 2020

Study information

• Verified date: May 2021
• Source: Kind Pharmaceuticals LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this phase I study is to evaluate the food effect on the PKs of AND017 following oral single-dose administration in healthy non-elderly Chinese subjects.

Description:

This is a single-center, randomized, open-label, two-sequence, two-period crossover study in healthy non-elderly Chinese subjects to evaluate the food effect on the pharmacokinetics, as well as PD and safety of AND017 following oral single-dose administration

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: August 21, 2020
• Est. primary completion date: August 16, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. BMI between 19.0~26.0 kg/m2 (both inclusive); Body weight =50 kg for male, and =45 kg for female.

2. Healthy participants having no clinical significant abnormalities of examinations during screening period and at the time of informed consent

3. Have no pregnancy plan in the next six months and are willing to take effective contraceptive methods.

Exclusion Criteria:

1. Allergic constitution or has a history of allergy to AND017 capsule and its excipient;

2. Subjects with low blood pressure or a risk of low blood pressure: systolic pressure <90 mmHg, diastolic pressure<60 mmHg.

3. Subjects with difficulty in venous blood sampling;

4. Subjects with a history of drug abuse within the past five years or who have abused drug within the past three months before screening;

5. Subjects smoking more than five cigarettes a day or nicotine dependent within the past three months before screening;

6. Subjects drinking alcohol more than 14 U/week within the past six months or used any alcohol products in two days pre-dose;

7. Subjects that have received any medication within the past 4 weeks pre-dose;

8. Subjects that have taken food or drink that has the potential to induce or inhibit drug metabolizing enzymes in the liver within one-week pre-dose;

9. Subjects that have taken any food or drink that contains or can be metabolized to caffeine or xanthine from 48 hours pre-dose to the last PK or PD blood sampling;

10. Subjects with diseases or factors of clinical abnormalities that need to be excluded, including but not limited to the nervous system, cardiovascular system, kidney, liver, gastrointestinal, respiratory system, metabolism, and skeletal system diseases, or other factors that may affect drug absorption, distribution, metabolism and excretion;

11. Subjects that have used HIF-PHIs within the past one year;

12. Subjects positive in HIV-Ab, HBsAg or HBeAg, or HCV-Ab, TP-Ab;

13. Subjects that have participated in any other clinical trials within the past three months pre-dose in the study;

14. Female subjects of childbearing age who are pregnant, lactating, or planning pregnancy; or have a positive in pregnancy test during the study;

15. Subjects with a history of blood donation or had a blood loss more than 400 mL within three months before screening;

16. Subjects that have special requirements on diet and cannot follow the dietary program indicated in the study;

17. Subjects that are unable to comply with research requirements or with any factors are considered not suitable for participating in the study according to the opinion of the investigator.

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Drug:
• AND017
AND017 oral capsule

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Kind Pharmaceuticals LLC

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax	Maximum Observed Plasma Concentration for AND017	Day 1 and Day 6, 0-72 hours post-dose
Primary	AUC0-inf	Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for AND017	Day 1 and Day 6, 0-72 hours post-dose