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AzTrials

Alzheimer DiseasePhase 1NCT05787041

The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects

A Phase 1 study testing high-fat diet group（AD16 20mg） and fasted group（AD16 20mg） in people with Alzheimer Disease, run by South China Center For Innovative Pharmaceuticals at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study was a single-center, randomized, open-access, two-crossover, single-dose study design with 16 subjects to evaluate the pharmacokinetics of a high-fat diet on a single dose of oral AD16 tablets in healthy Chinese adults and the safety of a single dose of oral AD16 tablets in healthy Chinese adults. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
high-fat diet group（AD16 20mg） and fasted group（AD16 20mg）
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
14 Jun 2019to 14 Dec 2019
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

  • Healthy subjects were aged 18-45 years (including boundary values), male and female.
  • Weight ≥50kg (male) or ≥45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends).
  • Have fully understood this study, voluntarily participated in it, and signed the Informed Consent.
  • Subjects are able to communicate well with researchers and complete the study according to protocol.
  • The subjects were deemed to be in good health based on physical examination, medical history, vital signs, electrocardiogram, chest X-ray, abdominal ultrasound, and laboratory tests.
  • Subject (including partner) is willing to have no pregnancy plan for the next 30 days (female subject) or 90 days (male subject) and is willing to use effective contraception.

Who cannot join

  • Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.
  • The patient has symptoms or related history of any serious disease, including but not limited to heart, liver, kidney, or other acute or chronic digestive tract or respiratory tract diseases, as well as diseases of the blood, endocrine, neurological, psychiatric and other systems, or any other disease or physiological condition that can interfere with the study results.
  • A history of postural hypotension with frequent episodes.
  • A history of frequent nausea or vomiting due to any cause.
  • Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study.
  • Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center.
Show all 17Show fewer
  • Previous drug abuse history or positive urine drug screening during screening period.
  • Smokers who smoked more than 5 cigarettes a day in the 3 months before the test.
  • Heavy drinkers or regular drinkers in the 6 months prior to the study screening, who drank more than 14 units of alcohol per week (1 unit of alcohol ≈360 mL beer or 45 mL 40% spirits or 150 mL wine) or had a positive alcohol breath test during the screening period.
  • Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day.
  • Take food or drink rich in xanthine, grapefruit or alcohol, caffeine (e.g., dragon fruit, mango, grapefruit, chocolate, coffee or tea) within 48 hours before administration.
  • Surgical procedures, transfusions of blood or blood components in the month prior to study screening.
  • Blood loss or donation of more than 400 mL in the 2 months prior to screening.
  • Participated in other clinical studies and took experimental drugs within 3 months prior to study screening.
  • Study participants who had received any medication in the 28 days prior to screening.
  • Pregnant or lactating women or women who have had unprotected sex within 14 days.
  • Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Central South University Xiang Ya Hospital

    Changsha

Other trials in China

About this study

The study was a single-center, randomized, open-access, two-crossover, single-dose study design with 16 subjects to evaluate the pharmacokinetics of a high-fat diet on a single dose of oral AD16 tablets in healthy Chinese adults and the safety of a single dose of oral AD16 tablets in healthy Chinese adults.

Compared with fasting administration, a high-fat diet reduced the rate of AD16 tablet absorption in healthy adult subjects and had no effect on overall exposure to AD16.

The elimination and distribution characteristics of AD16 in vivo were similar under the conditions of feeding and fasting administration.

A single dose of AD16 tablets after fasting and high fat diet showed good safety.

Being tested
high-fat diet group（AD16 20mg）, fasted group（AD16 20mg）
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • high-fat diet group（AD16 20mg）Other

    AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food.

  • fasted group（AD16 20mg）Other

    Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug.

Study groups in NCT05787041
Study groupRoleWhat they receive
High-fat diet groupExperimentalA single dose of AD16 tablets was taken orally after a high fat diet
Receives: Other: high-fat diet group（AD16 20mg）
Fasting groupExperimentalA single dose of AD16 tablets was taken orally under fasting conditions
Receives: Other: fasted group（AD16 20mg）

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cmax of AD16

    Maximum (peak) plasma drug concentration

    Measured: Up to Day 10

  2. AUC 0-t of AD16

    Area under the plasma concentration-time curve(AUC) from time zero to time t

    Measured: Up to Day 10

  3. AUC 0-∞ of AD16

    Area under the plasma concentration-time curve(AUC) from time zero to infinity

    Measured: Up to Day 10

  4. t1/2 of AD16

    Elimination half-life (to be used in a one-compartment or noncompartmental model)

    Measured: Up to Day 10

  5. Tmax of AD16

    Time to reach the maximum (peak) plasma concentration following drug administration

    Measured: Up to Day 10

  6. CL/F of AD16

    CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).

    Measured: Up to Day 10

  7. Vd/F of AD16

    Apparent volume of distribution after non-intravenous administration

    Measured: Up to Day 10

  8. MRT of AD16

    Mean residence time(MRT)

    Measured: Up to Day 10

  9. λz of AD16

    Terminal disposition rate constant/terminal rate constant

    Measured: Up to Day 10

Secondary outcomes (7)

  1. Adverse events

    The number of adverse events

    Measured: day-7 to day 10

  2. Serious adverse events

    The number of serious adverse events

    Measured: day-7 to day 10

  3. Number of participants with abnormal laboratory test results

    Laboratory tests include blood routine, blood biochemistry, coagulation function and urine routine

    Measured: day-7 to day-1 and day10

  4. Number of participants with abnormal vital signs

    vital signs include Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.

    Measured: day-7 to day3 and day7 to day10

  5. Number of participants with abnormal 12- Lead ECG readings

    abnormal 12- Lead ECG

    Measured: day-7 to day-1 and days3 、10

  6. Number of participants with abnormal physical examination findings

    The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.

    Measured: day-7 to day-1 and day10

  7. Concomitant medication

    Any concomitant medication

    Measured: Up to Day 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2023
  2. Study start14 Jun 2019
  3. Primary completion14 Dec 2019
  4. Study completion14 Dec 2019

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05787041
Sponsor's protocol ID
SCCIP-AD16-2018-02
Status last verified
Nov 2023
First submitted
1 Mar 2023
Last updated
1 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Peng D, Xu S, Zou T, Wang Y, Ouyang W, Zhang Y, Dong C, Li D, Guo J, Shen Q, Hu X, Zhou W, Li X, Qin Q. Safety, tolerability, pharmacokinetics and effects of diet on AD16, a novel neuroinflammatory inhibitor for Alzheimer's disease: a randomized phase 1 study. BMC Med. 2023 Nov 23;21(1):459. doi: 10.1186/s12916-023-03126-9.

    PubMed 37996817

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing high-fat diet group（AD16 20mg） and fasted group（AD16 20mg） in people with Alzheimer Disease, run by South China Center For Innovative Pharmaceuticals 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 17 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 1 Dec 2023. 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 of AD16 (time frame: Up to Day 10). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05787041, which also lists 1 linked publication.

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 1 Dec 2023.

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