A Food-Effect Study of AND017 in Healthy Participants

NCT04712500 | Completed Phase 1

• 1 other identifier: AND017-CN-101
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

AND017: Fasted - Fed

EXPERIMENTAL

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: Fed - Fasted

EXPERIMENTAL

Subjects were randomized to receive single dose of AND017 under fed condition in Period 1 and under fasted condition in Period 2

Drug: AND017

Interventions

AND017 DRUG

AND017 oral capsule

AND017: Fasted - Fed; AND017: Fed - Fasted

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI between 19.0\~26.0 kg/m2 (both inclusive); Body weight ≥50 kg for male, and ≥45 kg for female.
• Healthy participants having no clinical significant abnormalities of examinations during screening period and at the time of informed consent
• Have no pregnancy plan in the next six months and are willing to take effective contraceptive methods.

You may not qualify if:

• Allergic constitution or has a history of allergy to AND017 capsule and its excipient;
• Subjects with low blood pressure or a risk of low blood pressure: systolic pressure \<90 mmHg, diastolic pressure\<60 mmHg.
• Subjects with difficulty in venous blood sampling;
• Subjects with a history of drug abuse within the past five years or who have abused drug within the past three months before screening;
• Subjects smoking more than five cigarettes a day or nicotine dependent within the past three months before screening;
• Subjects drinking alcohol more than 14 U/week within the past six months or used any alcohol products in two days pre-dose;
• Subjects that have received any medication within the past 4 weeks pre-dose;
• 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;
• 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;
• 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;
• Subjects that have used HIF-PHIs within the past one year;
• Subjects positive in HIV-Ab, HBsAg or HBeAg, or HCV-Ab, TP-Ab;
• Subjects that have participated in any other clinical trials within the past three months pre-dose in the study;
• Female subjects of childbearing age who are pregnant, lactating, or planning pregnancy; or have a positive in pregnancy test during the study;
• Subjects with a history of blood donation or had a blood loss more than 400 mL within three months before screening;

Sponsors & Collaborators

• Kind Pharmaceuticals LLC: lead

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215000, China

Location

Study Officials

• Yusha Zhu, MD PhD

  Kind Pharmaceuticals LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 15, 2021
• Study Start: July 30, 2020
• Primary Completion: August 16, 2020
• Study Completion: August 21, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)