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

NCT05787041 | Completed Phase 1

• 1 other identifier: SCCIP-AD16-2018-02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (9)

• Cmax of AD16

  Maximum (peak) plasma drug concentration

  Up to Day 10

• AUC 0-t of AD16

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

  Up to Day 10

• AUC 0-∞ of AD16

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

  Up to Day 10

• t1/2 of AD16

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

  Up to Day 10

• Tmax of AD16

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

  Up to Day 10

• CL/F of AD16

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

  Up to Day 10

• Vd/F of AD16

  Apparent volume of distribution after non-intravenous administration

  Up to Day 10

• MRT of AD16

  Mean residence time(MRT)

  Up to Day 10

• λz of AD16

  Terminal disposition rate constant/terminal rate constant

  Up to Day 10

Secondary Outcomes (7)

• Adverse events

  day-7 to day 10

• Serious adverse events

  day-7 to day 10

• Number of participants with abnormal laboratory test results

  day-7 to day-1 and day10

• Number of participants with abnormal vital signs

  day-7 to day3 and day7 to day10

• Number of participants with abnormal 12- Lead ECG readings

  day-7 to day-1 and days3 、10

Study Arms (2)

High-fat diet group

EXPERIMENTAL

A single dose of AD16 tablets was taken orally after a high fat diet

Other: high-fat diet group（AD16 20mg）

Fasting group

EXPERIMENTAL

A single dose of AD16 tablets was taken orally under fasting conditions

Other: fasted group（AD16 20mg）

Interventions

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.

High-fat diet group

fasted group（AD16 20mg） OTHER

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

Fasting group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• South China Center For Innovative Pharmaceuticals: lead
• Xiangya Hospital of Central South University: collaborator

Study Sites (1)

The Central South University Xiang Ya Hospital

Changsha, China

Location

Related Publications (1)

• 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.

  PMID: 37996817 DERIVED

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 28, 2023
• Study Start: June 14, 2019
• Primary Completion: December 14, 2019
• Study Completion: December 14, 2019
• Last Updated: December 1, 2023

Record last verified: 2023-11

Locations

CN (1)