Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration

Alzheimer's Disease Clinical Trial

— AD16  

Official title:

Safety, Tolerability and Pharmacokinetics of AD16 Tablets in Adult Healthy Subjects After Single Administration

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05787028
• Other study ID #: SCCIP-AD16-2018-01
• Status: Completed
• Phase: Phase 1
• Start date: January 30, 2019
• Est. completion date: May 31, 2020

Study information

• Verified date: November 2023
• Source: South China Center For Innovative Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study was to evaluate the safety, tolerability and pharmacokinetic characteristics of single administration of AD16 tablets in healthy adults under fasting conditions, and the secondary objective was to preliminarily evaluate the material balance of single administration of AD16 tablets in fasting conditions. The study is divided into two parts: preliminary test and formal test. The formal trial was a single-center, randomized, placebo-controlled, double-blind, dose-increasing study, with 5 dose groups (5mg, 10mg, 20mg, 30mg and 40mg, respectively). Ten subjects (male and female) were enrolled in each dose group, of which 8 received the experimental drug and 2 received placebo. Urine and fecal samples were collected in the 20mg dose group for material balance study.Urine and fecal samples were collected in the 20mg dose group for material balance study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

1. Healthy subjects were aged 18-45 years (including boundary values), male and female.

2. Weight =50kg (male) or =45kg (female), and body mass index (BMI) of 19-24kg/m2 (including the boundary values at both ends).

3. Have fully understood this study, voluntarily participated in it, and signed the Informed Consent.

4. Subjects are able to communicate well with researchers and complete the study according to protocol.

5. 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.

6. 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:

1. Positive for hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody.

2. 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.

3. A history of postural hypotension with frequent episodes.

4. A history of frequent nausea or vomiting due to any cause.

5. Any clear history of drug or food allergies, especially allergies to ingredients similar to the drugs in this study.

6. Have special dietary requirements and cannot comply with the uniform diet provided by the clinical research center.

7. Previous drug abuse history or positive urine drug screening during screening period.

8. Smokers who smoked more than 5 cigarettes a day in the 3 months before the test.

9. 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.

10. Excessive consumption of tea, coffee (more than 6 cups) and/or caffeinated beverages (more than 1L) per day.

11. Surgical procedures, transfusions of blood or blood components in the month prior to study screening.

12. Blood loss or donation of more than 400 mL in the 2 months prior to screening.

13. Participated in other clinical studies and took experimental drugs within 3 months prior to study screening.

14. Study participants who had received any medication in the 28 days prior to screening.

15. Pregnant or lactating women or women who have had unprotected sex within 14 days.

16. Those unable to complete the study for other reasons or deemed unsuitable for inclusion by the researcher.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• AD16 5mg?10mg?20mg?30mg?40mg?60mg?80mg
Take one AD16 tablet in the morning
• AD16 placebo 5mg?10mg?20mg?30mg?40mg?60mg?80mg
Participants will take a placebo pill matching AD16 once in the morning

Locations

Country	Name	City	State
China	The Central South University Xiang Ya Hospital	Changsha

Sponsors (2)

Lead Sponsor	Collaborator
South China Center For Innovative Pharmaceuticals	Xiangya Hospital of Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events	The number of adverse events	day-7 to day3
Primary	Serious adverse events	The number of serious adverse events	day-7 to day3
Primary	Number of participants with abnormal laboratory test results	Laboratory tests include Blood routine, blood biochemistry, coagulation function and urine routine	Screening period (day-7 to day-2) and day3
Primary	Number of participants with abnormal vital signs	Pulse, blood pressure, body temperature and respiratory rate were observed at different time points before and after medication.	day-7 to day3
Primary	Number of participants with abnormal 12-lead electrocardiogram readings	abnormal 12-lead electrocardiogram readings	Screening period (day-7 to day-2) and day3
Primary	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.	Screening period (day-7 to day-2) and day3
Primary	Concomitant Medication	Any concomitant medication	up to day3
Primary	Tmax of AD16	Time to reach the maximum (peak) plasma concentration following drug administration	day1 to day3
Primary	Cmax of AD16	Maximum (peak) plasma drug concentration	day1 to day3
Primary	t1/2z of AD16	Elimination half-life (to be used in a one-compartment or noncompartmental model)	day1 to day3
Primary	AUC 0-8 of AD16	AUC 0-8 is defined as the concentration of drug extrapolated to infinite time (area under the plasma concentration versus time curve extrapolated to infinite time).; area under curve(AUC)	day1 to day3
Primary	AUC 0-t of AD16	AUC 0-t is defined as the concentration of drug from time zero to the last quantifiable concentration.area under curve(AUC)	day1 to day3
Primary	CL/F of AD16	CL/F is defined as the ratio of total clearance(CL) to bioavailability(F).; administration	day1 to day3
Primary	Vd/F of AD16	Apparent volume of distribution after non-intravenous administration	day1 to day3
Primary	?z of AD16	Terminal disposition rate constant/terminal rate constant	day1 to day3
Primary	Mean retention time(MRT )of AD16	Mean retention time from first dosing to t hours or mean retention time from first dosing to infinity	day1 to day3
Secondary	Ae	The amount of drug excreted in urine at t hours after administration The amount of drug excreted by fecal sample at t hours after administration	day-3 to day3
Secondary	Fe0-t	Cumulative excretion rate of drugs through urine Cumulative rate of drug excretion through feces	day-3 to day3
Secondary	Renal clearance	Renal clearance of drug from plasma	day-3 to day3