Safety and Pharmacokinetic of Donepezil Pamoate in Healthy Subjects

NCT03932916 | Completed Phase 1 DMC

• 1 other identifier: DON101-CTP
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AD

Outcome Measures

Primary Outcomes (5)

• Cmax of Donepezil

  Maximum observed concentration of drug substance in plasma.

  Blood samples collected over a 35 days period

• Tmax of Donepezil

  Time when the maximum concentration is acheived

  Blood samples collected over a 35 days period

• 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

• AUC0-∞ of Donepezil

  Area under the concentration-time curve from time zero to infinity.

  Blood samples collected over a 35 days period

• 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

Study Arms (3)

experimental group 1

EXPERIMENTAL

HHT201 17mg injection

Drug: Donepezil Pamoate for Injection 17mg

experimental group 2

EXPERIMENTAL

HHT201 34mg injection

Drug: Donepezil Pamoate for Injection 34mg

experimental group 3

ACTIVE COMPARATOR

Donepezil Hydrochloride oral tablet 5mg

Drug: Donepezil Hydrochloride 5mg

Interventions

Donepezil Pamoate for Injection 17mg DRUG

A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.

Also known as: HHT201

experimental group 1

Donepezil Pamoate for Injection 34mg DRUG

A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.

Also known as: HHT201

experimental group 2

Donepezil Hydrochloride 5mg DRUG

A tablet of 5mg Donepezil Hydrochloride will be administered once.

Also known as: Aricept

experimental group 3

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders
• Resting pulse rate \<55/min or \>100/min; Sitting systolic blood pressure \<90mmHg or \>140mmHg, diastolic blood pressure \<60mmHg or \>90mmHg
• ALT or Cr, BUN exceeding the upper limit of normal value; test results of urine protein was "++"
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody
• History or presence of drug or alcohol abuse
• Positive pregnancy test result, or plan to be pregnant if female
• An unwillingness or inability to comply with food and beverage restrictions within 24 hours prior to dosing
• Participation in any other investigational drug trial within 30 days prior to screening.

Sponsors & Collaborators

• Shanghai Synergy Pharmaceutical Sciences Co., Ltd.: lead

Study Sites (1)

Shanghai mental health center

Shanghai, Shanghai Municipality, 200030, China

Location

MeSH Terms

Interventions

Injections; Donepezil

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Study Officials

• Huafang Li, PhD

  Shanghai Mental Health Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 23, 2019
• First Posted: May 1, 2019
• Study Start: July 2, 2019
• Primary Completion: August 6, 2020
• Study Completion: September 11, 2020
• Last Updated: September 29, 2020

Record last verified: 2020-09

Locations

CN (1)