HealthyPhase 1NCT05151146
A Phase 1 Study of ANJ900 Chinese Healthy Subjects
A Phase 1 study testing ANJ900 and Metformin IR in people with Healthy, run by Anji Pharma at 1 site in China.
Trial summary
This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- ANJ900 and Metformin IR
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 15 Oct 2021to 28 Feb 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Chinese males or females between 18 and 65 years of age, inclusive.
- Body mass index between 18.5 and 28.0 kg/m2, inclusive, with a body weight >50 kg (males) or >45 kg (females).
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG (including heart rate ≥50 bpm, PR interval <200 ms, and QRS duration <120 ms), vital signs measurements (systolic blood pressure ≥90 and <140 mmHg and diastolic blood pressure ≥50 and <90 mmHg), and clinical laboratory evaluations at screening and Day -1 as assessed by the investigator (or designee).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3.
- Able to comprehend and willing to sign an ICF, remain at the study site, and to abide by the study restrictions.
Who cannot join
- Significant history or clinical manifestation of any metabolic, allergic (eg, asthma, urticaria, eczema dermatitis), dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Malignancy within 5 years (except basal cell skin carcinoma).
- History of a clinically significant disease that affects drug absorption, metabolism, or elimination processes, as determined by the investigator (or designee), including, but not limited to:
- inflammatory bowel disease, gastritis, ulcers, bile duct stones, or internal bleeding of the gastrointestinal tract or rectum
- gastrointestinal surgery (eg, anastomosis or bowel resection)
- pancreatic injury or pancreatitis
Show all 26Show fewer
- urinary tract obstruction or difficulty passing urine.
- History of hypoglycaemic episodes, severe unconscious hypoglycaemia, or glucose metabolism disorders.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound (eg, metformin), food, or other substance, unless approved by the investigator (or designee).
- Active symptoms, or a recent diagnosis of, coronavirus disease-19 (COVID-19).
- Donation or loss of >500 mL of blood within 4 weeks prior to screening.
- Receipt of blood products within 8 weeks prior to screening.
- Participation in a clinical study involving administration of an investigational drug (new chemical entity) in the past 3 months.
- Poor peripheral venous access or intolerant of venous blood collection.
- Use or intend to use any prescription medications (with the exception of paracetamol [≤4000 mg/day] or ibuprofen [≤2400 mg/day]) within 4 weeks or 5 half lives, whichever is longer, prior to screening.
- Use or intend to use any over the counter medications (with the exception of paracetamol [≤4000 mg/day], ibuprofen [≤2400 mg/day], and topical over the counter medications for external use), herbal medications, or food supplements (eg, vitamins or mineral supplements) within 2 weeks or 5 half lives, whichever is longer, prior to screening.
- Fasting plasma glucose <3.9 mmol/L or >6.1 mmol/L at screening or Day -1.
- Alanine aminotransferase, aspartate aminotransferase, or direct bilirubin >1.5 × the upper limit of normal at screening or Day -1.
- Positive hepatitis panel, human immunodeficiency virus test, or syphilis test.
- History of alcoholism or drug/chemical abuse within 12 months.
- Alcohol consumption of >21 units per week for males and >14 units for females. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
- Have consumed foods and beverages containing caffeine, xanthine, alcohol, or components that affect the absorption, metabolism, and excretion of drugs (eg, grapefruit or Seville oranges) within 48 hours prior to check-in.
- Have smoked >5 cigarettes or use the equivalent tobacco or nicotine containing products per day in the past 3 months, or are unwilling to abstain from smoking cigarettes or use the equivalent tobacco or nicotine containing products from 48 hours prior to Day -1 until discharge.
- Are unwilling to abstain from strenuous exercise from 48 hours prior to Day -1 until discharge.
- Positive alcohol breath test, urine drugs of abuse test, or urine cotinine test.
- Subjects who, in the opinion of the investigator (or designee), should not participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Investigate the Pharmacokinetics of ANJ900 (Metformin Hydrochloride Delayed-release Tablets) and the Effect of Food on the Pharmacokinetics of ANJ900 in Chinese Healthy Subjects
This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.
Read the detailed description
This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.
All subjects will receive each of the following treatments:
- Treatment 1: A single dose of 1800 mg ANJ900 in the fasted state.
- Treatment 2: A single dose of 1800 mg ANJ900 in the fed state.
- Treatment 3: A single dose of 1000 mg metformin IR in the fasted state. Potential subjects will be screened to assess their eligibility to enter the study within 14 days prior to the first dose administration. Subjects will be admitted into the study site on Days 1, 7, and 14 and will be confined to the study site until discharge on Days 3, 10, and 17 respectively.
- Conditions
- Healthy
- Being tested
- ANJ900, Metformin IR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ANJ900Drug
Also called Met DR
Metformin hydrochloride delayed-release tablets
Metformin IRDrug
Also called Met IR
metformin hydrochloride
| Study group | Role | What they receive |
|---|---|---|
| ANJ900 in the fasted state | Experimental | Single dose (1800 mg) of ANJ900 Receives: Drug: ANJ900 |
| ANJ900 in the fed state | Experimental | Single dose (1800 mg) of ANJ900 Receives: Drug: ANJ900 |
| Metformin IR in the fasted state | Active comparator | Single dose (1000 mg) of metformin IR Receives: Drug: Metformin IR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterize the AUC of single oral dose of ANJ900 in healthy Chinese subjects
ANJ900 levels in blood will be collected in serial draws
Measured: 1 week
Characterize Cmax of a single oral dose of ANJ900 in healthy Chinese subjects
ANJ900 levels in blood will be collected in serial draws
Measured: 1 week
Secondary outcomes (2)
Characterize the urine excretion from time zero to 24 hours post does of metformin
Urine will be analyzed for ANJ900
Measured: 1 week
Assess the safety of ANJ900 in healthy Chinese subjects
Adverse events will be collected and reported
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start15 Oct 2021
- Primary completion30 Dec 2021
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anji Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dongyang Liu, MD, Principal investigator, Peking University Third HospitalHaiyan Liu, MD, Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151146
- Sponsor's protocol ID
- ANJ900D1104
- Status last verified
- Jun 2022
- First submitted
- 16 Nov 2021
- Last updated
- 8 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Investigate the Pharmacokinetics of ANJ900 (Metformin Hydrochloride Delayed-release Tablets) and the Effect of Food on the Pharmacokinetics of ANJ900 in Chinese Healthy Subjects
- ClinicalTrials.gov ID
- NCT05151146
- Acronym / sponsor ID
- ANJ900D1104
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Anji PharmaIndustry (pharma, biotech, devices)
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 9 Dec 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.
This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.
Detailed description
This will be a Phase 1, randomised, open label, 3 way crossover study in healthy male and female Chinese subjects. Subjects will participate in 3 treatment periods and will be randomised in a 1:1:1 ratio to 1 of 3 treatment sequences. There will be a washout period of 7 days between doses.
All subjects will receive each of the following treatments:
- Treatment 1: A single dose of 1800 mg ANJ900 in the fasted state.
- Treatment 2: A single dose of 1800 mg ANJ900 in the fed state.
- Treatment 3: A single dose of 1000 mg metformin IR in the fasted state. Potential subjects will be screened to assess their eligibility to enter the study within 14 days prior to the first dose administration. Subjects will be admitted into the study site on Days 1, 7, and 14 and will be confined to the study site until discharge on Days 3, 10, and 17 respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ANJ900 in the fasted state | Experimental | Drug: ANJ900Single dose (1800 mg) of ANJ900 |
| ANJ900 in the fed state | Experimental | Drug: ANJ900Single dose (1800 mg) of ANJ900 |
| Metformin IR in the fasted state | Active comparator | Drug: Metformin IRSingle dose (1000 mg) of metformin IR |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chinese males or females between 18 and 65 years of age, inclusive.
- Body mass index between 18.5 and 28.0 kg/m2, inclusive, with a body weight >50 kg (males) or >45 kg (females).
- In good health, determined by no clinically significant findings from medical history, physical examination, 12 lead ECG (including heart rate ≥50 bpm, PR interval <200 ms, and QRS duration <120 ms), vital signs measurements (systolic blood pressure ≥90 and <140 mmHg and diastolic blood pressure ≥50 and <90 mmHg), and clinical laboratory evaluations at screening and Day -1 as assessed by the investigator (or designee).
- Females will not be pregnant or lactating, and females of childbearing potential and males will agree to use contraception as detailed in Appendix 3.
- Able to comprehend and willing to sign an ICF, remain at the study site, and to abide by the study restrictions.
Key exclusion criteria (26 listed)
- Significant history or clinical manifestation of any metabolic, allergic (eg, asthma, urticaria, eczema dermatitis), dermatological, hepatic, renal, haematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
- Malignancy within 5 years (except basal cell skin carcinoma).
- History of a clinically significant disease that affects drug absorption, metabolism, or elimination processes, as determined by the investigator (or designee), including, but not limited to:
- History of hypoglycaemic episodes, severe unconscious hypoglycaemia, or glucose metabolism disorders.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound (eg, metformin), food, or other substance, unless approved by the investigator (or designee).
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 |
|---|---|---|
| ANJ900Also: Met DRMetformin hydrochloride delayed-release tablets | Drug | ANJ900 in the fasted state, ANJ900 in the fed state |
| Metformin IRAlso: Met IRmetformin hydrochloride | Drug | Metformin IR in the fasted state |
Primary outcome
Characterize the AUC of single oral dose of ANJ900 in healthy Chinese subjects
Time frame: 1 week
ANJ900 levels in blood will be collected in serial draws
Characterize Cmax of a single oral dose of ANJ900 in healthy Chinese subjects
Time frame: 1 week
ANJ900 levels in blood will be collected in serial draws
2 secondary outcomes
Characterize the urine excretion from time zero to 24 hours post does of metformin
Time frame: 1 week
Assess the safety of ANJ900 in healthy Chinese subjects
Time frame: 3 weeks
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 8 Jun 2022.
- 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.
Dongyang Liu, MD principal investigator
Peking University Third Hospital
Haiyan Liu, MD principal investigator
Peking University Third Hospital
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 ANJ900 and Metformin IR in people with Healthy, run by Anji Pharma 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 26 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 8 Jun 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?
Characterize the AUC of single oral dose of ANJ900 in healthy Chinese subjects (time frame: 1 week). 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?
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 8 Jun 2022.