Diabetes Mellitus, Type 2Phase 1NCT06247748
Influence of JY09 on Pharmacokinetics of Metformin , Rosuvastatin , and Digoxin and the QT Interval Study in Overweight Chinese Subjects
A Phase 1 study testing Exendin-4 Fc fusion protein (JY09) injection, Metformin Hydrochloride tablet and Rosuvastatin calcium tablets in people with Diabetes Mellitus, Type 2 and Overweight, run by Beijing Dongfang Biotech Co., Ltd. at 1 site in China.
Trial summary
This trial is conducted in china. The aim of the trial is as follows: To assess the effect of multiple subcutaneous injections of JY09 injection on the pharmacokinetic (PK) profile of multiple oral doses of metformin hydrochloride tablets, a single oral dose of Rosuvastatin calcium tablets, or digoxin tablets in… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Overweight
- What is being tested?
- Exendin-4 Fc fusion protein (JY09) injection, Metformin Hydrochloride tablet and Rosuvastatin calcium tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteChina
- Study dates
- 19 Oct 2023to 15 Apr 2024
- 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
- Age: Overweight subjects with full capacity for civil behavior who are ≥ 18 years old and ≤ 45 years old (the ratio of the number of subjects of either sex is not less than 1/3).
- Body weight: men ≥ 50.0 kg, women ≥ 45.0 kg, body mass index (BMI) ≥ 24.0 kg/m2 and ≤ 28.0 kg/m2 , BMI = weight (kg)/height (m2 ).
- Those who do not plan to have children in the last 6 months, do not plan to donate sperm/eggs, and are willing to use effective contraception for 6 months after the end of dosing.
- Fully understand the trial and possible adverse effects, have the ability to communicate normally with the investigator, as well as comply with study requirements, follow protocol procedures and limitations, and be able to visit on time.
- Understand the content of the informed consent form, agree to participate in this trial and voluntarily sign the consent form.
Who cannot join
- A clear history of central nervous system, cardiovascular system, renal, hepatic, pulmonary, metabolic, and musculoskeletal disorders or other notable diseases.
- Individuals with gastrointestinal disorders, such as history of hepatobiliary disease, history of gastrointestinal disease, history of gastrointestinal surgery (except appendectomy) or history of chronic pancreatitis or idiopathic acute pancreatitis, and those with habitual diarrhea.
- Previous tip-twisting ventricular tachycardia or other risk factors that can lead to malignant arrhythmias, or a family history of first-degree relatives (i.e., biological parents, siblings, or children) with short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or sudden infant death syndrome in young adulthood (less than/equal to 40 years of age), or cardiac conduction block.
- Have disorders of electrolyte metabolism such as hyperkalemia, hypokalemia, hypomagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia.
- If the results of vital signs (blood pressure, pulse, respiration, temperature) are abnormal and clinically significant, a retest is allowed to confirm the results if they are abnormal, and the abnormal values of each vital sign.
- Physical examination, laboratory tests, 12-lead electrocardiogram (ECG), abdominal ultrasound, calcitonin and chest radiographs (orthopantomograms) suggesting the presence of abnormalities judged by the investigator to be clinically significant (retesting was allowed once).
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- Smokers who smoked an average of more than 5 cigarettes per day in the 3 months prior to screening or who could not give up smoking during their participation in the trial or who had a positive smoke test.
- Those who have participated in other clinical trials as a subject within 3 months prior to screening.
- Those who donated blood or blood products ≥400 mL within 3 months prior to screening.
- Those who cannot tolerate venipuncture and have a history of needle and blood sickness.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital drug clinical trial Institute
Beijing, Beijing Municipality
About this study
Official title: Evaluation of the Effects of Exendin-4 Fc Fusion Protein (JY09) Injection on the Pharmacokinetic Profiles of Metformin Hydrochloride Tablets, Rosuvastatin Calcium Tablets, and Digoxin Tablets and on the QT Interval in Overweight Chinese Subjects
This trial is conducted in china. The aim of the trial is as follows:
- To assess the effect of multiple subcutaneous injections of JY09 injection on the pharmacokinetic (PK) profile of multiple oral doses of metformin hydrochloride tablets, a single oral dose of Rosuvastatin calcium tablets, or digoxin tablets in overweight Chinese subjects;
- To assess the effect of multiple subcutaneous injections of JY09 injection on QT interval in overweight Chinese subjects.
- Conditions
- Diabetes Mellitus, Type 2, Overweight
- Being tested
- Exendin-4 Fc fusion protein (JY09) injection, Metformin Hydrochloride tablet, Rosuvastatin calcium tablets, Digoxin tablet
- Keywords
- JY09, QT Interval
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exendin-4 Fc fusion protein (JY09) injectionDrug
Also called JY09
D22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29, D36, D43, D50, D57, D64, D71, and D78 subjects returned to the study center to receive a subcutaneous abdominal injection of 2.4 mg of JY09 injection(total of 8 administrations).All doses were to be administered within 3 min.
Metformin Hydrochloride tabletDrug
Also called Metformin
D1 to D4 continuous oral administration of 0.5 g metformin hydrochloride tablets twice daily (D4 was administered only in the morning, with a total of 7 administrations) for a washout period of 96 h;0.5 g metformin hydrochloride tablets orally twice a day continuously from D85 to D88 (D88 was given only in the morning, for a total of 7 doses).
Rosuvastatin calcium tabletsDrug
Also called Rosuvastatin
D8 received a single oral administration of 10 mg of Rosuvastatin calcium tablets in the morning, with a washout period of 168 h,and 10 mg Rosuvastatin calcium tablets orally at 72 h ± 0.5 h (D95) after JY09 administration.
Digoxin tabletDrug
Also called digoxin
D15 received a single oral administration of 0.25 mg digoxin tablets in the morning, with a washout period of 168 h,oral 0.25 mg digoxin tablets 72 h±0.5 h after JY09 administration (D102)
| Study group | Role | What they receive |
|---|---|---|
| Exendin-4 Fc fusion protein (JY09) injection | Experimental | D22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29 to D78 received continuous subcutaneous abdominal injections of 2.4 mg of JY09 injection in the morning, once weekly (total of 8 administrations). All doses were to be administered within 3 min. Receives: Drug: Exendin-4 Fc fusion protein (JY09) injection; Drug: Metformin Hydrochloride tablet; Drug: Rosuvastatin calcium tablets; Drug: Digoxin tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Metformin Peak Concentration (Cmax )
The peak concentration(Cmax） is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Measured: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
Area under the Metformin blood concentration-time curve
AUC refers to the area under the drug time curve, which is the area surrounded by the pharmacokinetic blood concentration curve to the time axis. This parameter is an important index to evaluate the degree of drug absorption, reflecting the exposure characteristics of drugs in vivo.
Measured: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
The Rosuvastatin Peak Concentration (Cmax )
The peak concentration(Cmax） is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Measured: From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
Area under the Rosuvastatin blood concentration-time curve
Area under curve(AUC) refers to the area under the drug time curve, which is the area surrounded by the pharmacokinetic blood concentration curve to the time axis. This parameter is an important index to evaluate the degree of drug absorption, reflecting the exposure characteristics of drugs in vivo.
Measured: From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
The Digoxin Peak Concentration (Cmax )
The peak concentration(Cmax） is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Measured: From time 0 to 168 hours after a single dose of Digoxin without JY09 exposure (Day 15) and at JY09 steady state (Day 102)
Baseline-corrected difference of Corrected QT interval after multiple subcutaneous injections of JY09 injection
Corrected QT interval is a QT interval adjusted by heart rate, which is an index of cardiac depolarization and repolarization
Measured: From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92)
Secondary outcomes (11)
Safety endpoint-Adverse events
All adverse medical events occurring after the subject receives the experimental drug, which may be manifested as symptoms, signs, diseases, or abnormalities in laboratory tests, but may not necessarily have a causal relationship with the experimental drug.
Measured: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Blood pressure
Blood pressure includes systolic and diastolic blood pressure.
Measured: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Pulse
Pulse refers to the pulsation formed in the arteries when the heart contracts, due to the flow of blood from the heart into the arteries. Pulse is one of the vital signs of human body, and it is an important index to measure heart rate and blood pressure.
Measured: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Respiration
Respiration refers to the process of gas exchange between the body and the outside world.
Measured: From baseline (Day -1) to follow-up (Day 123)
Physical examination
Include general condition, skin, neck (including thyroid), head (including eyes, ears, nose, throat), chest, abdomen, back, lymph nodes, limbs, and nervous system.
Measured: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Routine blood
Blood routine refers to the examination of blood conditions and diseases by observing the changes in the number and morphological distribution of blood cells.
Measured: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Blood biochemistry
Blood biochemical examination can determine the content of sugars, lipids, hormones, ions and other substances in the blood, and provide help for the diagnosis and treatment of diseases.
Measured: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Urine routine
Urine routine is of great significance not only for the observation of the curative effect of the diagnosis of urinary system diseases, but also for the diagnosis and prognosis of other system diseases.
Measured: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-coagulation function
The coagulation function test is mainly to find out whether the clotting factors in the patient's body are abnormal.
Measured: From baseline (Day -1) to follow-up (Day 123)
12-lead electrocardiogram (ECG)
Electrocardiogram (ECG) is an objective index of the occurrence, propagation and recovery of cardiac excitation. It is used for the examination of various arrhythmias, ventricular and atrial hypertrophy, myocardial infarction, arrhythmia, myocardial ischemia and other diseases.
Measured: From baseline (Day -1) to follow-up (Day 123)
Immunogenicity
Immunogenicity refers to the performance that can cause an immune response, that is, the antigen can stimulate specific immune cells, so that immune cells activation, proliferation, differentiation, and eventually produce immune effecting substances antibodies and sensitized lymphocytes.
Measured: From baseline (Day -1) to follow-up (Day 123)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2024
- Study start19 Oct 2023
- Primary completion15 Apr 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247748
- Sponsor's protocol ID
- dfbt-jy09-ow-2023-101
- Status last verified
- Aug 2024
- First submitted
- 22 Jan 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Exendin-4 Fc Fusion Protein (JY09) Injection on the Pharmacokinetic Profiles of Metformin Hydrochloride Tablets, Rosuvastatin Calcium Tablets, and Digoxin Tablets and on the QT Interval in Overweight Chinese Subjects
- ClinicalTrials.gov ID
- NCT06247748
- Acronym / sponsor ID
- dfbt-jy09-ow-2023-101
- Conditions
- Diabetes Mellitus, Type 2, Overweight
- Keywords
- JY09, QT Interval
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Beijing Dongfang Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 15 Apr 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 8 Feb 2024 (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.
This trial is conducted in china. The aim of the trial is as follows:
- To assess the effect of multiple subcutaneous injections of JY09 injection on the pharmacokinetic (PK) profile of multiple oral doses of metformin hydrochloride tablets, a single oral dose of Rosuvastatin calcium tablets, or digoxin tablets in overweight Chinese subjects;
- To assess the effect of multiple subcutaneous injections of JY09 injection on QT interval in overweight Chinese subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exendin-4 Fc fusion protein (JY09) injection | Experimental | Drug: Exendin-4 Fc fusion protein (JY09) injection, Drug: Metformin Hydrochloride tablet, Drug: Rosuvastatin calcium tablets, Drug: Digoxin tabletD22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29 to D78 received continuous subcutaneous abdominal injections of 2.4 mg of JY09 injection in the morning, once weekly (total of 8 administrations). All doses were to be administered within 3 min. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: Overweight subjects with full capacity for civil behavior who are ≥ 18 years old and ≤ 45 years old (the ratio of the number of subjects of either sex is not less than 1/3).
- Body weight: men ≥ 50.0 kg, women ≥ 45.0 kg, body mass index (BMI) ≥ 24.0 kg/m2 and ≤ 28.0 kg/m2 , BMI = weight (kg)/height (m2 ).
- Those who do not plan to have children in the last 6 months, do not plan to donate sperm/eggs, and are willing to use effective contraception for 6 months after the end of dosing.
- Fully understand the trial and possible adverse effects, have the ability to communicate normally with the investigator, as well as comply with study requirements, follow protocol procedures and limitations, and be able to visit on time.
- Understand the content of the informed consent form, agree to participate in this trial and voluntarily sign the consent form.
Key exclusion criteria (10 listed)
- A clear history of central nervous system, cardiovascular system, renal, hepatic, pulmonary, metabolic, and musculoskeletal disorders or other notable diseases.
- Individuals with gastrointestinal disorders, such as history of hepatobiliary disease, history of gastrointestinal disease, history of gastrointestinal surgery (except appendectomy) or history of chronic pancreatitis or idiopathic acute pancreatitis, and those with habitual diarrhea.
- Previous tip-twisting ventricular tachycardia or other risk factors that can lead to malignant arrhythmias, or a family history of first-degree relatives (i.e., biological parents, siblings, or children) with short QT syndrome, long QT syndrome, unexplained sudden death, drowning, or sudden infant death syndrome in young adulthood (less than/equal to 40 years of age), or cardiac conduction block.
- Have disorders of electrolyte metabolism such as hyperkalemia, hypokalemia, hypomagnesemia, hypomagnesemia, hypercalcemia or hypocalcemia.
- If the results of vital signs (blood pressure, pulse, respiration, temperature) are abnormal and clinically significant, a retest is allowed to confirm the results if they are abnormal, and the abnormal values of each vital sign.
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 |
|---|---|---|
| Exendin-4 Fc fusion protein (JY09) injectionAlso: JY09D22 received a single subcutaneous abdominal injection of 1.2 mg of JY09 injection after completion of PK blood sampling; D29, D36, D43, D50, D57, D64, D71, and D78 subjects returned to the study center to receive a subcutaneous abdominal injection of 2.4 mg of JY09 injection(total of 8 administrations).All doses were to be administered within 3 min. | Drug | Exendin-4 Fc fusion protein (JY09) injection |
| Metformin Hydrochloride tabletAlso: MetforminD1 to D4 continuous oral administration of 0.5 g metformin hydrochloride tablets twice daily (D4 was administered only in the morning, with a total of 7 administrations) for a washout period of 96 h;0.5 g metformin hydrochloride tablets orally twice a day continuously from D85 to D88 (D88 was given only in the morning, for a total of 7 doses). | Drug | Exendin-4 Fc fusion protein (JY09) injection |
| Rosuvastatin calcium tabletsAlso: RosuvastatinD8 received a single oral administration of 10 mg of Rosuvastatin calcium tablets in the morning, with a washout period of 168 h,and 10 mg Rosuvastatin calcium tablets orally at 72 h ± 0.5 h (D95) after JY09 administration. | Drug | Exendin-4 Fc fusion protein (JY09) injection |
| Digoxin tabletAlso: digoxinD15 received a single oral administration of 0.25 mg digoxin tablets in the morning, with a washout period of 168 h,oral 0.25 mg digoxin tablets 72 h±0.5 h after JY09 administration (D102) | Drug | Exendin-4 Fc fusion protein (JY09) injection |
Primary outcome
The Metformin Peak Concentration (Cmax )
Time frame: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
The peak concentration(Cmax） is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Area under the Metformin blood concentration-time curve
Time frame: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)
AUC refers to the area under the drug time curve, which is the area surrounded by the pharmacokinetic blood concentration curve to the time axis. This parameter is an important index to evaluate the degree of drug absorption, reflecting the exposure characteristics of drugs in vivo.
The Rosuvastatin Peak Concentration (Cmax )
Time frame: From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
The peak concentration(Cmax） is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Area under the Rosuvastatin blood concentration-time curve
Time frame: From time 0 to 96 hours after a single dose of Rosuvastatin without JY09 exposure (Day 8) and at JY09 steady state (Day 95)
Area under curve(AUC) refers to the area under the drug time curve, which is the area surrounded by the pharmacokinetic blood concentration curve to the time axis. This parameter is an important index to evaluate the degree of drug absorption, reflecting the exposure characteristics of drugs in vivo.
The Digoxin Peak Concentration (Cmax )
Time frame: From time 0 to 168 hours after a single dose of Digoxin without JY09 exposure (Day 15) and at JY09 steady state (Day 102)
The peak concentration(Cmax） is the highest level of plasma concentration that occurs after administration.This parameter is an important index to reflect the absorption rate and degree of drug in vivo.
Baseline-corrected difference of Corrected QT interval after multiple subcutaneous injections of JY09 injection
Time frame: From time 0 to 72 hours after a single dose of JY09 (Day 22) and at JY09 steady state (Day 92)
Corrected QT interval is a QT interval adjusted by heart rate, which is an index of cardiac depolarization and repolarization
11 secondary outcomes
Safety endpoint-Adverse events
Time frame: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Blood pressure
Time frame: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Pulse
Time frame: From baseline (Day -1) to follow-up (Day 123)
Vital signs-Respiration
Time frame: From baseline (Day -1) to follow-up (Day 123)
Physical examination
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Routine blood
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Blood biochemistry
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-Urine routine
Time frame: From baseline (Day -1) to follow-up (Day 123)
Laboratory tests-coagulation function
Time frame: From baseline (Day -1) to follow-up (Day 123)
12-lead electrocardiogram (ECG)
Time frame: From baseline (Day -1) to follow-up (Day 123)
Immunogenicity
Time frame: From baseline (Day -1) to follow-up (Day 123)
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 21 Aug 2024.
- 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.
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 Exendin-4 Fc fusion protein (JY09) injection, Metformin Hydrochloride tablet and Rosuvastatin calcium tablets in people with Diabetes Mellitus, Type 2 and Overweight, run by Beijing Dongfang Biotech 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 10 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 21 Aug 2024. 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?
The Metformin Peak Concentration (Cmax ) (time frame: During a dosing interval (0-36 hours) after the last of 7 repeated doses of metformin without JY09 exposure (Day 4) and at JY09 steady state (Day 88)). The study lists 6 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 21 Aug 2024.