Trial Outcomes & Findings for Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers (NCT NCT04617782)
NCT ID: NCT04617782
Last Updated: 2024-09-19
Results Overview
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
35 days of each Treatment
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Treatment Sequence ABC or ACB in Crossover Fashion
All subjects were assigned to receive all treatments, with a different sequence in treatment periods 2 and 3.
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment C: 10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
|---|---|
|
Treatment A - 5 mg TDS
STARTED
|
60
|
|
Treatment A - 5 mg TDS
COMPLETED
|
57
|
|
Treatment A - 5 mg TDS
NOT COMPLETED
|
3
|
|
Treatment B - 10 mg TDS
STARTED
|
55
|
|
Treatment B - 10 mg TDS
COMPLETED
|
53
|
|
Treatment B - 10 mg TDS
NOT COMPLETED
|
2
|
|
Treatment C - 10 mg Oral
STARTED
|
56
|
|
Treatment C - 10 mg Oral
COMPLETED
|
53
|
|
Treatment C - 10 mg Oral
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment Sequence ABC or ACB in Crossover Fashion
All subjects were assigned to receive all treatments, with a different sequence in treatment periods 2 and 3.
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment C: 10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
|---|---|
|
Treatment A - 5 mg TDS
Physician Decision
|
2
|
|
Treatment A - 5 mg TDS
failure to follow site rules
|
1
|
|
Treatment B - 10 mg TDS
Protocol Violation
|
1
|
|
Treatment B - 10 mg TDS
Withdrawal by Subject
|
1
|
|
Treatment C - 10 mg Oral
Protocol Violation
|
2
|
|
Treatment C - 10 mg Oral
failure to follow site rules
|
1
|
Baseline Characteristics
Pharmacokinetic Study of 5 and 10 mg Corplex™ Donepezil TDS Compared to 10 mg Aricept® in Healthy Volunteers
Baseline characteristics by cohort
| Measure |
All Study Participants
n=60 Participants
Participants were assigned to receive treatment sequence ABC or ACB in a crossover fashion.
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment C: 10 mg/day Aricept® donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
|---|---|
|
Age, Continuous
|
39.8 years
STANDARD_DEVIATION 9.91 • n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black of African American
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
56 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 35 days of each TreatmentPopulation: all subjects without major protocol deviations that could affect PK and who had at least one PK parameter derived
To evaluate steady-state donepezil plasma exposure (Cmax) following 5 weeks of treatment.
Outcome measures
| Measure |
Treatment A 5 mg TDS
n=60 Participants
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout;
|
Treatment B 10 mg TDS
n=55 Participants
Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout;
|
Treatment C 10 mg Oral
n=56 Participants
Treatment C: 10 mg/day oral donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
|---|---|---|---|
|
Maximum Concentration (Cmax)
|
29.9 Cmax ng/ml
Standard Deviation 9.1
|
62.4 Cmax ng/ml
Standard Deviation 19.9
|
70.5 Cmax ng/ml
Standard Deviation 19.4
|
PRIMARY outcome
Timeframe: 35 days each TreatmentPopulation: all subjects without major protocol deviations that could affect PK and who had at least one PK parameter derived
To evaluate steady-state donepezil plasma exposure (AUC) following 5 weeks of treatment
Outcome measures
| Measure |
Treatment A 5 mg TDS
n=60 Participants
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout;
|
Treatment B 10 mg TDS
n=55 Participants
Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout;
|
Treatment C 10 mg Oral
n=56 Participants
Treatment C: 10 mg/day oral donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
|---|---|---|---|
|
Area Under the Curve (AUC)
|
4366.0 AUC h*ng/mL
Standard Deviation 1380.1
|
9099.0 AUC h*ng/mL
Standard Deviation 2972.1
|
8462.6 AUC h*ng/mL
Standard Deviation 2558.0
|
Adverse Events
Treatment A - 5 mg TDS
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Treatment B - 10 mg TDS
Serious events: 0 serious events
Other events: 30 other events
Deaths: 0 deaths
Treatment C - 10 mg Oral
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment A - 5 mg TDS
n=60 participants at risk
Participants received treatment sequence ABC or ACB in a randomized, crossover fashion.
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment C: 10 mg/day oral donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
Treatment B - 10 mg TDS
n=55 participants at risk
Participants received treatment sequence ABC or ACB in a randomized, crossover fashion.
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment C: 10 mg/day oral donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
Treatment C - 10 mg Oral
n=56 participants at risk
Participants received treatment sequence ABC or ACB in a randomized, crossover fashion.
Treatment A: 5 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment B: 10 mg/day Donepezil TDS 1-week wear and applied weekly for 5 consecutive weeks, then 1 day washout; Treatment C: 10 mg/day oral donepezil tablet administered QD for 5 consecutive weeks, then 1 day washout;
|
|---|---|---|---|
|
Gastrointestinal disorders
Constipation
|
15.0%
9/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
5.5%
3/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
17.9%
10/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Gastrointestinal disorders
Nausea
|
6.7%
4/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
1.8%
1/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
30.4%
17/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Gastrointestinal disorders
Diarrhoea
|
3.3%
2/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
3.6%
2/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
12.5%
7/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Gastrointestinal disorders
Abdominal Pain
|
0.00%
0/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
5.5%
3/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
1.8%
1/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
0.00%
0/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
5.4%
3/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
General disorders
Application Site Pruritis
|
20.0%
12/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
9.1%
5/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
0.00%
0/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
General disorders
Application Site Dermatitis
|
8.3%
5/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
5.5%
3/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
1.8%
1/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
General disorders
Fatigue
|
3.3%
2/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
1.8%
1/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
8.9%
5/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
General disorders
Application Site Irritation
|
5.0%
3/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
0.00%
0/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
0.00%
0/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Nervous system disorders
Headache
|
13.3%
8/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
14.5%
8/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
12.5%
7/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Nervous system disorders
Dizziness
|
5.0%
3/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
3.6%
2/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
19.6%
11/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Nervous system disorders
Somnolence
|
0.00%
0/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
0.00%
0/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
10.7%
6/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Psychiatric disorders
Insomnia
|
6.7%
4/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
7.3%
4/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
0.00%
0/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Psychiatric disorders
Nightmare
|
8.3%
5/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
1.8%
1/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
1.8%
1/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
6.7%
4/60 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
9.1%
5/55 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
8.9%
5/56 • Collected from first dose of the study drug to last treatment day, 36 days per intervention for a total of 108 days
|
Additional Information
Ronald Tashjian, Sr. Director of Clinical Operations
Corium, Inc.
Phone: 6172337474
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place