A Food-Effect Study of AND017 in Healthy Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: AND017

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215000
      • The First Affiliated Hospital of Soochow University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cmax	Maximum Observed Plasma Concentration for AND017	Day 1 and Day 6, 0-72 hours post-dose
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

Collaborators and Investigators

• Sponsor: Kind Pharmaceuticals LLC

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): August 16, 2020
• Study Completion (Actual): August 21, 2020

Study Registration Dates

• First Submitted: January 13, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): May 11, 2021
• Last Update Submitted That Met QC Criteria: May 7, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: AND017-CN-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No