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Type 2 DiabetesPhase 1NCT04907006

A Food-drug Interaction Study of SY-004 in Healthy Subjects

A Phase 1 study testing SY-004 capsule in people with Type 2 Diabetes, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.

Completed

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

Official record
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Trial summary

A randomized, open, two cycle, double crossover, single center study was conducted to evaluate the effect of high-fat diet on the pharmacokinetics of SY-004 in healthy subjects Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Type 2 Diabetes
What is being tested?
SY-004 capsule
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
1 siteChina
Study dates
31 Aug 2021to 11 Oct 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • The subjects can communicate well with the researchers, understand and comply with the requirements of this study, and sign the informed consent voluntarily.
  • Age on the day of signing the informed consent: healthy subjects aged 18 or above, both male and female.
  • At the time of screening, male weight ≥ 50.0 kg, female weight ≥ 45.0 kg, 19.0 kg / m2 ≤ BMI ≤ 26.0 kg / m2.
  • Fasting blood glucose ≥ 3.9 mmol / L and < 6.1 mmol / L.
  • From one month before the informed consent to three months after the last medication, the subjects and their partners had no plans to have a child, take effective contraceptive measures voluntarily, and donate sperm or eggs.

Who cannot join

  • Within 3 months before screening, a clinical trial was completed or withdrawn, or a clinical trial was currently in progress, or other medical trials were conducted. The researchers judged that it was not suitable for the trial.
  • In the past, there were serious systematic diseases or family history (including cardiovascular system, digestive system, urinary system, etc.), the researchers judged that the disease status could significantly change the absorption, distribution, metabolism and excretion of the drug used in the trial, or the risk of the subjects would be increased by taking the trial drug.
  • Allergic constitution, or food allergy history, or known to be allergic to study drug / similar drug.
  • Previous history of hypoglycemia.
  • Previous patients with postural hypotension.
  • The past five years have been positive for drug abuse, drug use history or urine drug screening results.
Show all 21Show fewer
  • Those who donate blood or lose more than 400ml of blood within 4 weeks before screening, or who have received blood or blood component infusion within 4 weeks before screening, or who plan to donate blood components within 3 months after the end of the study.
  • Those who have history of syncope or blood sickness, who cannot tolerate venous puncture or have difficulty in blood collection.
  • Severe infection, trauma or surgical operation within 4 weeks prior to screening, or those who are scheduled to perform surgery during the study (including, but not limited to, dental operations).
  • Use any prescription, over-the-counter, herbal or health care product within 2 weeks prior to screening.
  • Any drugs that inhibit or induce the metabolism of liver drugs were used within 30 days before screening.
  • The average alcohol intake in the first three months of screening was more than 14 units per week (1 unit = 360ml beer, 45ml of alcohol content of 40% spirits or wine 150ml), or those who could not give up drinking alcohol during the test, or those who were positive for alcohol exhalation.
  • Smoking was ≥ 5 cigarettes per day within 3 months before screening, or unwilling / unable to give up smoking during the trial.
  • Special requirements for diet, and those who cannot comply with the unified diet arrangement.
  • No guarantee of chocolate, any caffeine or food or drink (such as Firedragon fruit, grapefruit, grapefruit, orange juice, mango, etc.) 48 hours before and during the test.
  • Pregnant or lactating women, or pregnant women with positive results.
  • The results of screening were positive for HBsAg, HCV, TP and HIV.
  • ALT > 1.5 times of normal value was found in screening（ × ULN), or glutamic transaminase (AST) >1.5 × ULN, or serum total bilirubin (TBIL) > 1.5 × ULN。
  • The results of 12 lead ECG were: QT interval (qtcb) >450ms (male) or >470ms (female).
  • The results of physical examination, vital signs, abdominal B-ultrasound (liver, gallbladder, pancreas, spleen and kidney), chest CT, ECG, laboratory examination items and related auxiliary examination results were judged by the researchers to be unsuitable for the participants.
  • The researchers judged that the subjects with other factors were not suitable for participating in the test.

Trial locations and contacts

1 site in 1 country.

China1 site

  • XIE Haitang

    Wuhu, Anhui, 241000

Other trials in China

About this study

Official title: A Randomized, Open-label, Two-period, Double Crossover, Single Center Study to Evaluate the Effect of High-fat Diet on the Pharmacokinetics of SY-004 in Healthy Subjects

A randomized, open, two cycle, double crossover, single center study was conducted to evaluate the effect of high-fat diet on the pharmacokinetics of SY-004 in healthy subjects

Read the detailed description

This study will evaluate the effect of high-fat diet on the pharmacokinetics of SY-004.

Conditions
Type 2 Diabetes
Being tested
SY-004 capsule
Keywords
Food drug interaction，Hypoglycemic drugs，SY-004
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

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

  • SY-004 capsuleDrug

    After fasting for 10 hours, subjects in group 1 took one SY-004 (80mg) orally on an empty stomach on the day of administration with 240ml warm water; Subjects in group 2 began to eat high-fat breakfast 30 minutes before administration , and took one SY-004 capsule（80mg） orally with 240ml warm water. The subjects in both groups were fasted within 4 hours after taking the medicine, and drinking water was forbidden within 1 hour before and after taking SY-004.

Study groups in NCT04907006
Study groupRoleWhat they receive
Group-1ExperimentalThe subjects in both groups will be fasting overnight for at least 10 hours before administration. In Group-1 on D1, subjects will be orally administered with one SY-004 capsule(80mg ) on an empty stomach with 240ml warm water; In Group-2, subjects will have high-fat breakfast 30 minutes before administration ,then take one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups will be fasted within 4 hours after taking the medicine, and drinking water is forbidden within 1 hour before and after taking the medicine. After the cleaning period (D9-D16), the subjects will exchang the way of taking medicine and enter the second cycle of drug administration.
Receives: Drug: SY-004 capsule
Group-2ExperimentalThe subjects in both groups will be fasting overnight for at least 10 hours before administration. In Group-1 on D1, subjects will be orally administered with one SY-004 capsule(80mg ) on an empty stomach with 240ml warm water; In Group-2, subjects will have high-fat breakfast 30 minutes before administration ,then take one SY-004 capsule(80mg) orally with 240ml warm water. The subjects in both groups will be fasted within 4 hours after taking the medicine, and drinking water is forbidden within 1 hour before and after taking the medicine. After the cleaning period (D9-D16), the subjects will exchang the way of taking medicine and enter the second cycle of drug administration.
Receives: Drug: SY-004 capsule

What is being measured

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

  1. AUC0-t

    Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC) 0-t of SY-004 in human plasma.

    Measured: 8 days

  2. AUC0-∞

    Under fasting and high-fat diet, Area under the plasma concentration versus time curve (AUC)0 - ∞ of SY-004 in human plasma.

    Measured: 8 days

  3. Cmax

    Under fasting and high-fat diet, Peak Plasma Concentration (Cmax) of SY-004 in human plasma.

    Measured: 8 days

Secondary outcomes (3)

  1. Tmax、t1/2z、CLz/F

    Under fasting and high-fat diet, Peak time(Tmax) of SY-004 in human plasma.

    Measured: 8 days

  2. t1/2z

    Under fasting and high-fat diet, Half life (T1/2z) of SY-004 in human plasma.

    Measured: 8 days

  3. CLz/F

    Under fasting and high-fat diet, clearance (Cl) of SY-004 in human plasma.

    Measured: 8 days

Timeline

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

  1. First posted28 May 2021
  2. Study start31 Aug 2021
  3. Primary completion11 Oct 2021
  4. Study completion11 Oct 2021

Resources

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
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04907006
Sponsor's protocol ID
SY004004
Status last verified
May 2021
First submitted
15 May 2021
Last updated
18 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SY-004 capsule in people with Type 2 Diabetes, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. 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 5 inclusion and 21 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 18 May 2022. 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?

AUC0-t (time frame: 8 days). The study lists 3 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 NCT04907006.

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 18 May 2022.

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