Diet, High-FatPhase 1NCT05486598
A Study of Diet Influence of AL8326 in Chinese Healthy Adult Subjects
A Phase 1 study testing AL8326 tablets in people with Diet, High-Fat and Pharmacokinetics, run by Advenchen Laboratories Nanjing Ltd. at 1 site in China.
Trial summary
Main study objective: the pharmacokinetic effects of high-fat diet on AL8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects. Secondary study objectives: safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diet, High-Fat, Pharmacokinetics
- What is being tested?
- AL8326 tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- 21 Jun 2022to Dec 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
- Healthy male or female subjects aged 18 ~ 65 years (including both 18 and 65 years);
- Body weight ≥ 50 kg for men and ≥ 45 kg for women, with a body mass index in the range 19-26 kg / m^2 (inclusive 19 and 26) (BMI = body weight (kg) / height2 (M2));
- No mental abnormalities, no history of cardiovascular, nervous, respiratory, digestive, urinary, endocrine and metabolic abnormalities;
- Previous history, physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation routine, pregnancy test (female), hepatitis, HIV, syphilis, 12 lead electrocardiogram, chest X-ray and other tests in the screening period, the whole of the results must be within the normal range matched to age and gender, or meet the protocol regulations, or if outside the normal range is judged as "not clinically significant (NCS) ";
- Those who agree to be abstinent or have taken effective non drug contraception for the duration of the study and for at least 3 months after last study drug administration (for female subjects also required to be abstinent or have taken effective non drug contraception for two weeks prior to study entry);
- Subject is able to communicate well with investigator and understand and comply with all requirements of this study, understand and sign the informed consent form.
Who cannot join
- Allergic constitution (allergy to two or more substances) or known allergy to the study drug or to the same drug;
- The screening period examination was abnormal and clinically significant.
- Regular use of sedative, hypnotic, or other addictive drugs within 6 months before enrollment;
- Those with a history of substance abuse or a positive urine drug abuse screen within 12 months prior to enrollment;
- Those who smoked more than 5 cigarettes per day, or could not stop using any tobacco products during the trial;
- Regular drinkers with a positive alcohol insufflation test or within 6 months prior to enrollment, who consumed more than 3 units of alcohol per day, or more than 21 units per week (one bottle of 350 ml of beer with 120 ml of liquor or 30 ml of spirits as 1 drinking unit);
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- Use of any prescription drug, Chinese herbal medicine within 4 weeks prior to enrollment, and / or use of any over-the-counter (OTC), food supplement (including vitamins, calcium tablets, etc.) within 2 weeks prior to first dose;
- Had participated in other clinical trials and taken study drugs within 3 months before enrollment;
- Having a blood donor (blood donation with ingredients) or blood loss of 400 ml, or having a blood transfusion within 3 months before enrollment; Blood donation (component containing blood donation) or blood loss of 200 ml within 1 month before enrollment (except physiological blood loss in females);
- History of significant illness or major surgery, trauma, 3 months prior to screening.
- Had gastrointestinal disease causing clinically significant symptoms such as nausea, vomiting, diarrhea, or malabsorption syndrome or a history of severe vomiting, diarrhea within the week prior to enrollment;
- Pregnant, lactating female subjects and reproductive age female subjects unable to provide contraception on request;
- Hepatitis B surface antigen positive, hepatitis C antibody positive, syphilis antibody positive, HIV antibody positive persons;
- Special requirements for the diet (including lactose intolerance), inability to comply with the diet provided and respective prescribers;
- Subject denied discontinuation of any beverage or food containing methylxanthine, e.g., caffeine (coffee, tea, cola, chocolate, etc.), 48 hours prior to first dose until the end of study;
- Subject denied discontinuation of any beverage or food containing grapefruit 7 days prior to first dose until the end of the study;
- Intolerance to venipuncture for blood collection or poor vascular status;
- Subjects who, in the judgment of the investigator, were not suitable for participation in this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong, 266000
Xiaolei Zhang, 053282912611, qingyilunli@126.com
About this study
Official title: A Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects
Main study objective: the pharmacokinetic effects of high-fat diet on AL8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Secondary study objectives: safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects
Read the detailed description
This is a Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects.
Sixteen healthy subjects were randomly divided into two sequence groups, a and B, and eight subjects in each sequence group were dosed according to either the fasting → postprandial or the postprandial → fasting sequence. The washout period was 14 days.
- Conditions
- Diet, High-Fat, Pharmacokinetics
- Being tested
- AL8326 tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL8326 tabletsDrug
Also called AL8326
Sequence A group: on the 1st day, take a single dose of AL8326 tablets on an empty stomach. On the 15th day, take a single dose of AL8326 tablets after meals.
Sequence B group: on the 1st day after meal, take a single dose of AL8326 tablets; on the 15th day, take a single dose of AL8326 tablets on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| AL8326(Fasting） | Experimental | After screening, the subjects were randomly assigned to two sequence groups A and B. after fasting at least 10 hours overnight, they took al8326 tablets according to the requirements of two sequence groups A and B. Receives: Drug: AL8326 tablets |
| AL8326（Postprandial） | Experimental | After screening, the subjects were randomly assigned to two sequence groups A and B. after fasting at least 10 hours overnight, they took al8326 tablets according to the requirements of two sequence groups A and B. Receives: Drug: AL8326 tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-t
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Measured: 120 hours after each dose
AUC0-∞
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Measured: 120 hours after each dose
Cmax
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Measured: 120 hours after each dose
Secondary outcomes (3)
Tmax
Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
Measured: 120 hours after each dose
T1/2
Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
Measured: 120 hours after each dose
Incidence of adverse events / serious adverse events as well as severity
Safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects.
Measured: Day 15 (± 1) after the last Administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start21 Jun 2022
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet, High-FatStudies 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
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yu Cao, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05486598
- Sponsor's protocol ID
- AL8326-CN-009
- Status last verified
- Aug 2022
- First submitted
- 2 Jun 2022
- Last updated
- 3 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT05486598
- Acronym / sponsor ID
- AL8326-CN-009
- Conditions
- Diet, High-Fat, Pharmacokinetics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Advenchen Laboratories Nanjing Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 3 Aug 2022 (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.
Main study objective: the pharmacokinetic effects of high-fat diet on AL8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Secondary study objectives: safety and tolerability of a single oral dose of AL8326 tablets in healthy subjects
Detailed description
This is a Phase IB Clinical Trial to Evaluate the Effect of High-fat Diet on Pharmacokinetics of AL8326 Tablets in Chinese Healthy Adult Subjects.
Sixteen healthy subjects were randomly divided into two sequence groups, a and B, and eight subjects in each sequence group were dosed according to either the fasting → postprandial or the postprandial → fasting sequence. The washout period was 14 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AL8326(Fasting） | Experimental | Drug: AL8326 tabletsAfter screening, the subjects were randomly assigned to two sequence groups A and B. after fasting at least 10 hours overnight, they took al8326 tablets according to the requirements of two sequence groups A and B. |
| AL8326（Postprandial） | Experimental | Drug: AL8326 tabletsAfter screening, the subjects were randomly assigned to two sequence groups A and B. after fasting at least 10 hours overnight, they took al8326 tablets according to the requirements of two sequence groups A and B. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy male or female subjects aged 18 ~ 65 years (including both 18 and 65 years);
- Body weight ≥ 50 kg for men and ≥ 45 kg for women, with a body mass index in the range 19-26 kg / m^2 (inclusive 19 and 26) (BMI = body weight (kg) / height2 (M2));
- No mental abnormalities, no history of cardiovascular, nervous, respiratory, digestive, urinary, endocrine and metabolic abnormalities;
- Previous history, physical examination, vital signs, blood routine, urine routine, blood biochemistry, coagulation routine, pregnancy test (female), hepatitis, HIV, syphilis, 12 lead electrocardiogram, chest X-ray and other tests in the screening period, the whole of the results must be within the normal range matched to age and gender, or meet the protocol regulations, or if outside the normal range is judged as "not clinically significant (NCS) ";
- Those who agree to be abstinent or have taken effective non drug contraception for the duration of the study and for at least 3 months after last study drug administration (for female subjects also required to be abstinent or have taken effective non drug contraception for two weeks prior to study entry);
Key exclusion criteria (18 listed)
- Allergic constitution (allergy to two or more substances) or known allergy to the study drug or to the same drug;
- The screening period examination was abnormal and clinically significant.
- Regular use of sedative, hypnotic, or other addictive drugs within 6 months before enrollment;
- Those with a history of substance abuse or a positive urine drug abuse screen within 12 months prior to enrollment;
- Those who smoked more than 5 cigarettes per day, or could not stop using any tobacco products during the trial;
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 |
|---|---|---|
| AL8326 tabletsAlso: AL8326Sequence A group: on the 1st day, take a single dose of AL8326 tablets on an empty stomach. On the 15th day, take a single dose of AL8326 tablets after meals. Sequence B group: on the 1st day after meal, take a single dose of AL8326 tablets; on the 15th day, take a single dose of AL8326 tablets on an empty stomach. | Drug | AL8326(Fasting）, AL8326（Postprandial） |
Primary outcome
AUC0-t
Time frame: 120 hours after each dose
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
AUC0-∞
Time frame: 120 hours after each dose
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
Cmax
Time frame: 120 hours after each dose
Effect of high fat diet on the pharmacokinetics of al8326 after oral administration of AL8326 tablets in Chinese healthy adult subjects.
3 secondary outcomes
Tmax
Time frame: 120 hours after each dose
T1/2
Time frame: 120 hours after each dose
Incidence of adverse events / serious adverse events as well as severity
Time frame: Day 15 (± 1) after the last Administration
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 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.
Yu Cao principal investigator
The Affiliated Hospital of Qingdao University
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 AL8326 tablets in people with Diet, High-Fat and Pharmacokinetics, run by Advenchen Laboratories Nanjing 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 6 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 3 Aug 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingyin Li (+8657188683590, anne@advenchen.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC0-t (time frame: 120 hours after each dose). 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 3 Aug 2022.