Healthy VolunteersPhase 1NCT04712500

A Food-Effect Study of AND017 in Healthy Participants

A Phase 1 study testing AND017 in people with Healthy Volunteers, run by Kind Pharmaceuticals LLC at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: AND017
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 14 participants
Where: 1 siteChina
Study dates: 30 Jul 2020to 21 Aug 2020
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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;

Show all 17Show fewer

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

Trial locations and contacts

1 site in 1 country.

China1 site

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

Other trials in China

About this study

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

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.

Read the 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

Conditions: Healthy Volunteers
Being tested: AND017

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AND017Drug
AND017 oral capsule

Study groups in NCT04712500
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: AND017

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax
Maximum Observed Plasma Concentration for AND017
Measured: 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
Measured: Day 1 and Day 6, 0-72 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jul 202021 Aug 2020

First posted15 Jan 2021
Study start30 Jul 2020
Primary completion16 Aug 2020
Study completion21 Aug 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Healthy VolunteersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 14 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04712500
Sponsor's protocol ID: AND017-CN-101
Status last verified: May 2021
First submitted: 13 Jan 2021
Last updated: 11 May 2021
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 11 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04712500
Acronym / sponsor ID: AND017-CN-101
Conditions: Healthy Volunteers
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 14 participants (actual)
Lead sponsor: Kind Pharmaceuticals LLCIndustry (pharma, biotech, devices)
Study start: 30 Jul 2020 (actual)
Primary completion: 16 Aug 2020 (actual)
Study completion: 21 Aug 2020 (actual)
First posted: 15 Jan 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
AND017: Fasted - Fed	Experimental	Drug: AND017Subjects were randomized to receive single dose of AND017 under fasted condition in Period 1 and under fed condition in Period 2
AND017: Fed - Fasted	Experimental	Drug: AND017Subjects were randomized to receive single dose of AND017 under fed condition in Period 1 and under fasted condition in Period 2

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (17 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AND017AND017 oral capsule	Drug	AND017: Fasted - Fed, AND017: Fed - Fasted

Primary outcome

Cmax
Time frame: Day 1 and Day 6, 0-72 hours post-dose
Maximum Observed Plasma Concentration for AND017
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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2021.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Yusha Zhu, MD PhD study director

Kind Pharmaceuticals LLC

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing AND017 in people with Healthy Volunteers, run by Kind Pharmaceuticals LLC at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax (time frame: Day 1 and Day 6, 0-72 hours post-dose). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04712500.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2021.