Clinical trial NCT04907019: A Drug Interaction Study of SY-004 Capsules in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Keywords: Drug interactions，rifampicin， Hypoglycemic drugs
Lead sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-05-28
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Within 3 months before screening, a clinical trial was completed or withdrawn, or a clinical trial was in progress, or participated in other medical trial activities, and the researcher judged that it was not suitable to participate in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.
* 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.

Primary outcomes:
measure: Cmax
timeFrame: 22 days
measure: AUC0-t
timeFrame: 22 days
measure: AUC0-∞
timeFrame: 22 days
Secondary outcomes:
measure: Tmax
timeFrame: 22 days
measure: T1/2z
timeFrame: 22 days
measure: CLz/F
timeFrame: 22 days
Other outcomes:
Locations:
city: Wuhu
country: China
facility: XIE Haitang
state: Anhui
Study officials:
References: