Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

AD Clinical Trial

Official title:

Evaluation of Safety and Pharmacokinetic Profiles of a Single-dose HHT201 in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03932916
• Other study ID #: DON101-CTP
• Status: Completed
• Phase: Phase 1
• Start date: July 2, 2019
• Est. completion date: September 11, 2020

Study information

• Verified date: September 2020
• Source: Shanghai Synergy Pharmaceutical Sciences Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this study is to evaluate the safety and pharmacokinetic profiles of HHT201 in healthy subjects.

Description:

The study aims to evaluate the safety, pharmacokinetics and to determine the potential dose limiting toxicity of HHT201 in healthy subjects between the ages of 20-59, 6 in 17mg dose group and 20 in 34mg dose group. Another 12 subjects will be administered a tablet of 5mg Donepezil Hydrochloride to get the PK profile of Donepezil as reference. Eligible subjects will be accepted into the protocol after review and providing voluntary written informed consent forms and completion of a comprehensive medical, physical examination, and routine laboratory assessment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: September 11, 2020
• Est. primary completion date: August 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 59 Years

Eligibility

Inclusion Criteria:

• Chinese healthy subjects, male or female

• between the ages of 20 and 60 years

• A body mass index (BMI), calculated as weight in kg/(height in m)², from 19 to 28 kg/m², and female weight=45kg, male weight=50kg

• Able to provide written informed consent forms

Exclusion Criteria:

1. Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders

2. Resting pulse rate <55/min or >100/min; Sitting systolic blood pressure <90mmHg or >140mmHg, diastolic blood pressure <60mmHg or >90mmHg

3. ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"

4. Clinically significant ECG abnormalities in screening or baseline, such as male QTc interval =450ms and female QTc interval =470ms, and were considered inappropriate for inclusion by the researchers

5. Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody

6. History or presence of drug or alcohol abuse

7. Positive pregnancy test result, or plan to be pregnant if female

8. An unwillingness or inability to comply with food and beverage restrictions within 24 hours prior to dosing

9. Participation in any other investigational drug trial within 30 days prior to screening.

Related Conditions & MeSH terms

• AD

Intervention

Drug:
• Donepezil Pamoate for Injection 17mg
A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
• Donepezil Pamoate for Injection 34mg
A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
• Donepezil Hydrochloride 5mg
A tablet of 5mg Donepezil Hydrochloride will be administered once.

Locations

Country	Name	City	State
China	Shanghai mental health center	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cmax of Donepezil	Maximum observed concentration of drug substance in plasma.	Blood samples collected over a 35 days period
Primary	Tmax of Donepezil	Time when the maximum concentration is acheived	Blood samples collected over a 35 days period
Primary	AUClast of Donepezil	Area under the concentration-time curve from time zero to time of last measurable concentration.	Blood samples collected over a 35 days period
Primary	AUC0-8 of Donepezil	Area under the concentration-time curve from time zero to infinity.	Blood samples collected over a 35 days period
Primary	t1/2 of Donepezil	The time when the concentraion of the drug eliminated to half of the initial.	Blood samples collected over a 35 days period