Type 2 DiabetesPhase 1NCT04907019
A Drug Interaction Study of SY-004 Capsules in Healthy Subjects
A Phase 1 study testing rifampicin，SY-004 in people with Type 2 Diabetes, run by Suzhou Yabao Pharmaceutical R&D Co., Ltd. at 1 site in China.
Trial summary
A single center, open-label, single sequence study was conducted to evaluate the potential drug interaction of CYP3A4 inducer rifampicin with SY-004 capsules 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?
- rifampicin，SY-004
- 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
- 6 Jul 2021to 17 Aug 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- Within 3 months before screening, a clinical trial was completed or withdrawn, or a clinical trial was in progress, or participated in other medical trial activities, and the researcher judged that it was not suitable to participate in this trial.
- With a history of serious systemic 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 experimental drugs, or taking experimental drugs would increase the risk of subjects.
- Allergic constitution, or history of food allergy, or known allergy to study drug / similar drug, or to rifampicin or rifamycin antibiotics.
- Patients with previous orthostatic hypotension.
- Those who had a history of drug abuse, drug abuse or positive urine drug screening results in the past five years.
- Those who donated blood or lost more than 400ml in 4 weeks before screening, or received transfusion of blood or blood components in 4 weeks before screening, or planned to donate blood components within 3 months after the end of the study.
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- Those who have a history of needle syncope or blood syncope, or who can't tolerate venipuncture for blood collection, or who have difficulty in blood collection.
- The patients with severe infection, trauma or major surgery within 4 weeks before the screening, or who plan to perform surgery during the study period (including but not limited to dental surgery).
- Use any prescription, over-the-counter, herbal or health products within 2 weeks before screening.
- Any drugs that inhibit or induce liver drug metabolizing enzymes were used within 30 days before screening.
- During the first three months of screening, the average alcohol intake was more than 14 units per week (1 unit = 360ml beer, 45ml spirits with 40% alcohol content or 150ml wine), or those who could not give up drinking during the test period, or those with positive alcohol breath.
- Smoking more than 5 cigarettes per day within 3 months before screening, or unwilling / unable to give up smoking during the trial.
- Those who have special requirements for diet and can not comply with the unified diet arrangement.
- It is not guaranteed that chocolate, any food or drink containing caffeine or possibly affecting the test results (such as pitaya, grapefruit, grapefruit, orange juice, mango, etc.) will be fasted 48 hours before administration and during the test.
- Pregnant or lactating women, or pregnancy test results were positive.
- The screening results of HBsAg, HCV, TP and HIV were positive.
- When screening, there was ALT > 1.5 times the upper limit of normal value（ × ULN), or ast > 1.5 × ULN, or TBIL > 1.5 × ULN。
- When screening, the 12 lead ECG showed the following results: 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 test related auxiliary examination in screening period were not suitable for the participants.
- According to the judgment of the researcher, the subjects with other factors not suitable to participate in the experiment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Open-label, Single Sequence Study to Evaluate the Potential Drug Interaction of CYP3A4 Inducer Rifampicin With SY-004 Capsules in Healthy Subjects
A single center, open-label, single sequence study was conducted to evaluate the potential drug interaction of CYP3A4 inducer rifampicin with SY-004 capsules in healthy subjects
- Conditions
- Type 2 Diabetes
- Being tested
- rifampicin，SY-004
- Keywords
- Drug interactions，rifampicin， Hypoglycemic drugs
- 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.
rifampicin，SY-004Drug
On the morning of D1, the subjects will take orally 80 mg of SY-004 Capsules on an empty stomach.Fasting will be performed within 4 hours after taking the medicine. From D8 to D14, the subjects will take orally 600 mg rifampicin before breakfast every day. On the day of D15, the subjects will take orally 600 mg rifampicin and 80 mg SY-004 Capsules on an empty stomach.
From D16 to D21, subjects will take orally 600 mg of rifampicin before breakfast every day.The patient can be discharged from the hospital after completing the safety examination on D22.
| Study group | Role | What they receive |
|---|---|---|
| Group-drugs interaction | Experimental | 24 subjects were enrolled in this study. The effects of rifampicin single dose and steady-state on the pharmacokinetics of sy-004 will be analyzed. Receives: Drug: rifampicin，SY-004 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Peak Plasma Concentration (Cmax) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Measured: 22 days
AUC0-t
Area under the plasma concentration versus time curve (AUC0-t)) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Measured: 22 days
AUC0-∞
Area under the plasma concentration versus time curve (AUC0-∞)) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Measured: 22 days
Secondary outcomes (3)
Tmax
Peak Time （Tmax）of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Measured: 22 days
T1/2z
Half time （T1/2z）of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Measured: 22 days
CLz/F
Clearance (Clz/F)of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
Measured: 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start6 Jul 2021
- Primary completion17 Aug 2021
- Study completion17 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04907019
- Sponsor's protocol ID
- SY004005
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Open-label, Single Sequence Study to Evaluate the Potential Drug Interaction of CYP3A4 Inducer Rifampicin With SY-004 Capsules in Healthy Subjects
- ClinicalTrials.gov ID
- NCT04907019
- Acronym / sponsor ID
- SY004005
- Conditions
- Type 2 Diabetes
- Keywords
- Drug interactions，rifampicin， Hypoglycemic drugs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Suzhou Yabao Pharmaceutical R&D Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 17 Aug 2021 (actual)
- Study completion
- 17 Aug 2021 (actual)
- First posted
- 28 May 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.
A single center, open-label, single sequence study was conducted to evaluate the potential drug interaction of CYP3A4 inducer rifampicin with SY-004 capsules in healthy subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group-drugs interaction | Experimental | Drug: rifampicin，SY-00424 subjects were enrolled in this study. The effects of rifampicin single dose and steady-state on the pharmacokinetics of sy-004 will be analyzed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (20 listed)
- Within 3 months before screening, a clinical trial was completed or withdrawn, or a clinical trial was in progress, or participated in other medical trial activities, and the researcher judged that it was not suitable to participate in this trial.
- With a history of serious systemic 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 experimental drugs, or taking experimental drugs would increase the risk of subjects.
- Allergic constitution, or history of food allergy, or known allergy to study drug / similar drug, or to rifampicin or rifamycin antibiotics.
- Patients with previous orthostatic hypotension.
- Those who had a history of drug abuse, drug abuse or positive urine drug screening results in the past five years.
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 |
|---|---|---|
| rifampicin，SY-004On the morning of D1, the subjects will take orally 80 mg of SY-004 Capsules on an empty stomach.Fasting will be performed within 4 hours after taking the medicine. From D8 to D14, the subjects will take orally 600 mg rifampicin before breakfast every day. On the day of D15, the subjects will take orally 600 mg rifampicin and 80 mg SY-004 Capsules on an empty stomach. From D16 to D21, subjects will take orally 600 mg of rifampicin before breakfast every day.The patient can be discharged from the hospital after completing the safety examination on D22. | Drug | Group-drugs interaction |
Primary outcome
Cmax
Time frame: 22 days
Peak Plasma Concentration (Cmax) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
AUC0-t
Time frame: 22 days
Area under the plasma concentration versus time curve (AUC0-t)) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
AUC0-∞
Time frame: 22 days
Area under the plasma concentration versus time curve (AUC0-∞)) of SY-004 when SY-004 capsules were treated with rifampicin alone or in combination with rifampicin at steady-state level
3 secondary outcomes
Tmax
Time frame: 22 days
T1/2z
Time frame: 22 days
CLz/F
Time frame: 22 days
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 18 May 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 rifampicin，SY-004 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 20 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?
Cmax (time frame: 22 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?
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.