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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
high-fat diet group(AD16 20mg)
fasted group(AD16 20mg)
Sponsored by
Xiangya Hospital of Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Sites / Locations

  • The Central South University Xiang Ya Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

High-fat diet group

Fasting group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Cmax of AD16
Maximum (peak) plasma drug concentration
AUC 0-t of AD16
Area under the plasma concentration-time curve(AUC) from time zero to time t
AUC 0-∞ of AD16
Area under the plasma concentration-time curve(AUC) from time zero to infinity
t1/2 of AD16
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Tmax of AD16
Time to reach the maximum (peak) plasma concentration following drug administration
CL/F of AD16
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Vd/F of AD16
Apparent volume of distribution after non-intravenous administration
MRT of AD16
Mean residence time(MRT)
λz of AD16
Terminal disposition rate constant/terminal rate constant

Secondary Outcome Measures

Adverse events
The number of adverse events
Serious adverse events
The number of serious adverse events
Number of participants with abnormal laboratory test results
Laboratory tests include blood routine, blood biochemistry, coagulation function and urine routine
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.
Number of participants with abnormal 12- Lead ECG readings
abnormal 12- Lead ECG
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.
Concomitant medication
Any concomitant medication

Full Information

First Posted
March 1, 2023
Last Updated
March 14, 2023
Sponsor
Xiangya Hospital of Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT05787041
Brief Title
The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects
Official Title
The Effect of High Fat Diet on the Pharmacokinetics of AD16 Tablets in Healthy Chinese Adult Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
June 14, 2019 (Actual)
Primary Completion Date
December 14, 2019 (Actual)
Study Completion Date
December 14, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
High-fat diet group
Arm Type
Experimental
Arm Description
A single dose of AD16 tablets was taken orally after a high fat diet
Arm Title
Fasting group
Arm Type
Experimental
Arm Description
A single dose of AD16 tablets was taken orally under fasting conditions
Intervention Type
Other
Intervention Name(s)
high-fat diet group(AD16 20mg)
Intervention Description
AD16 was administered with 240 mL water 30 minutes after the subjects ate a high-fat, high-calorie food.
Intervention Type
Other
Intervention Name(s)
fasted group(AD16 20mg)
Intervention Description
Subjects took AD16 on an empty stomach and fasted within 4 hours after taking the drug.
Primary Outcome Measure Information:
Title
Cmax of AD16
Description
Maximum (peak) plasma drug concentration
Time Frame
Up to Day 10
Title
AUC 0-t of AD16
Description
Area under the plasma concentration-time curve(AUC) from time zero to time t
Time Frame
Up to Day 10
Title
AUC 0-∞ of AD16
Description
Area under the plasma concentration-time curve(AUC) from time zero to infinity
Time Frame
Up to Day 10
Title
t1/2 of AD16
Description
Elimination half-life (to be used in a one-compartment or noncompartmental model)
Time Frame
Up to Day 10
Title
Tmax of AD16
Description
Time to reach the maximum (peak) plasma concentration following drug administration
Time Frame
Up to Day 10
Title
CL/F of AD16
Description
CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).
Time Frame
Up to Day 10
Title
Vd/F of AD16
Description
Apparent volume of distribution after non-intravenous administration
Time Frame
Up to Day 10
Title
MRT of AD16
Description
Mean residence time(MRT)
Time Frame
Up to Day 10
Title
λz of AD16
Description
Terminal disposition rate constant/terminal rate constant
Time Frame
Up to Day 10
Secondary Outcome Measure Information:
Title
Adverse events
Description
The number of adverse events
Time Frame
day-7 to day 10
Title
Serious adverse events
Description
The number of serious adverse events
Time Frame
day-7 to day 10
Title
Number of participants with abnormal laboratory test results
Description
Laboratory tests include blood routine, blood biochemistry, coagulation function and urine routine
Time Frame
day-7 to day-1 and day10
Title
Number of participants with abnormal vital signs
Description
vital signs include Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.
Time Frame
day-7 to day3 and day7 to day10
Title
Number of participants with abnormal 12- Lead ECG readings
Description
abnormal 12- Lead ECG
Time Frame
day-7 to day-1 and days3 、10
Title
Number of participants with abnormal physical examination findings
Description
The skin, mucosa, lymph nodes, head, neck, chest, abdomen, spine/limbs and nervous system were observed at different time points before and after medication.
Time Frame
day-7 to day-1 and day10
Title
Concomitant medication
Description
Any concomitant medication
Time Frame
Up to Day 10

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: 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. Exclusion Criteria: 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. 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.
Facility Information:
Facility Name
The Central South University Xiang Ya Hospital
City
Changsha
Country
China

12. IPD Sharing Statement

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

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