A Food-Effect Study of AND017 in Healthy Participants

• ClinicalTrials.gov Identifier: NCT04712500
• Recruitment Status: Completed
• First Posted: January 15, 2021
• Last Update Posted: May 11, 2021
• Sponsor: Kind Pharmaceuticals LLC
• Information provided by (Responsible Party): Kind Pharmaceuticals LLC

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Healthy Volunteers	Drug: AND017	Phase 1

Detailed 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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: July 30, 2020
• Actual Primary Completion Date: August 16, 2020
• Actual Study Completion Date: August 21, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: AND017: Fasted - Fed; Subjects were randomized to receive single dose of AND017 under fasted condition in Period 1 and under fed condition in Period 2	Drug: AND017; AND017 oral capsule
Experimental: AND017: Fed - Fasted; Subjects were randomized to receive single dose of AND017 under fed condition in Period 1 and under fasted condition in Period 2	Drug: AND017; AND017 oral capsule

Outcome Measures

Primary Outcome Measures :

1. Cmax [ Time Frame: Day 1 and Day 6, 0-72 hours post-dose ]
   Maximum Observed Plasma Concentration for AND017
2. AUC0-inf [ Time Frame: Day 1 and Day 6, 0-72 hours post-dose ]
   Area Under the Plasma Concentration-time Curve from Time 0 to Infinite Time for AND017

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

China, Jiangsu

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China, 215000

Sponsors and Collaborators

Kind Pharmaceuticals LLC

Investigators

• Study Director: Yusha Zhu, MD PhD; Kind Pharmaceuticals LLC

More Information

• Responsible Party: Kind Pharmaceuticals LLC
• ClinicalTrials.gov Identifier: NCT04712500
• Other Study ID Numbers: AND017-CN-101
• First Posted: January 15, 2021
• Last Update Posted: May 11, 2021
• Last Verified: May 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No