A Food-Effect Study of AND017 in Healthy Participants

May 7, 2021 updated by: Kind Pharmaceuticals LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Cmax
Time Frame: Day 1 and Day 6, 0-72 hours post-dose
Maximum Observed Plasma Concentration for AND017
Day 1 and Day 6, 0-72 hours post-dose
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
Day 1 and Day 6, 0-72 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kind Pharmaceuticals LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 30, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 21, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 13, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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