A Phase 1, Healthy Volunteer Study to Assess a Patch Delivery System for Alzheimer's type Dementia

Phase 1

Completed

• Conditions: Alzheimer's type dementia; Neurological - Alzheimer's disease; Neurological - Dementias

• Registration Number: ACTRN12620000199910
• Lead Sponsor: Corium Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-20
• Study Completion: 2020-08-18
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Key inclusion criteria include:

1.Healthy, adult, male or female, at least 18 years of age at Screening

2.Nonsmoker or occasional smoker (less than or equal to 1 cigarette or equivalent/day) and must agree not to smoke or agree to consume no more than 1 cigarette or equivalent/day from the Screening Visit until after the End of Study Visit.

3.Body mass index between 18.0 and 32.0 kg/m2 at Screening.

4.Sparse, minimal, and fine hair on skin at application sites

5.If a female of childbearing potential: must be either sexually inactive (abstinent) for at least 14 days prior to the first TDS application and remain sexually inactive throughout the study or be using an acceptable birth control methods while within the study

6.A female of nonchildbearing potential: defined as either postmenopausal with amenorrhea for at least 1 year prior to Screening AND have an acceptable follicle-stimulating hormone serum level, or have official documentation of at least 1 of the sterilization procedure no less than 6 months prior to Screening.

7.For a male: must agree to an acceptable birth control methods from Screening until after the End of Study Visit

Exclusion Criteria

Key exclusion criteria include:

1.History of any clinically significant medical or psychiatric condition or disease that, in the opinion of the investigator, might confound the results of the study or poses an additional risk to the subject by participation in the study.

2.History of alcoholism or drug abuse within the past 2 years prior to the first study product treatment, or current alcohol or drug abuse.

3.History of significant multiple, severe contact allergies or has had 1 or more anaphylactic reactions, or is significantly intolerant to prescription or nonprescription drugs.

4.Exhibiting symptoms suggestive of bladder outflow obstruction as assessed by the investigator.

5.Has intolerance to venipuncture and/or inability to comply with the extensive blood sampling required for this study or does not have suitably intact veins in both arms.

6.Potential for occupational exposure to anticholinesterase agents in the 5 weeks prior to Screening through the last TDS removal.

7.Female subjects with a positive pregnancy test or who are lactating

8.History or presence of hairy skin on application sites that may potentially interfere with TDS adhesion and drug absorption. Clipping is permitted to remove fine or sparse hair. Subjects with heavy hair growth at the application site will not be eligible even with clipping.

9.History or presence of significant skin damage, diffuse skin diseases, scars, tattoos on the application sites, or other skin disturbances or coloration that would interfere with placement of test articles, skin assessment, or reactions to drug as deemed by the investigator to potentially interfere with drug absorption or irritation assessments; subjects with a spray tan applied less than 30 days prior to study dose are excluded.

10.History or presence of significant dermatological disease or condition, such as atopy, psoriasis, vitiligo or conditions that are known to alter the skin appearance or physiologic response

11.History of or current consumption of high levels of caffeine (equivalent to 3 regular cups of coffee or 2 energy drinks, per day).

12.Donation of blood or significant blood loss within 56 days prior to the first study product treatment.

13.Plasma donation within 7 days prior to the first study product treatment.

14.Use of donepezil HCl or related drugs within 60 days prior to the first study product treatment.

15.Clinically significant depression symptoms or suicidal ideation or behavior

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary objective of this study is to assess relative bioavailability of donepezil from a single application of once-weekly Corplex™ Donepezil Transdermal Delivery Systems (TDS) with crystals compared to Corplex Donepezil TDS without crystals.[Blood samples for donepezil PK will be collected at the following time points: Prior to TDS application (0 hour) and at 2, 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 170, 174, 180, 192, 216, 240, 288, 312, 360, 432, 504, 600, 672, 696, and 840 hours following Corplex Donepezil TDS application. The patch is removed at 168 hours post application.]

Secondary Outcome Measures

Name	Time	Method
The secondary objective of this study is to evaluate the safety and tolerability (including local skin irritation) of Corplex Donepezil TDS.[Skin irritation assessments will be performed prior to TDS application and at 0.5, 24, 48, and 72 hours following TDS removal.<br><br>Safety will be monitored throughout the study by repeated clinical and laboratory evaluations.<br><br>Physical exams: Screening, Day -1, and Day 36 of each treatment.<br><br>12-Lead Electrocardiogram: Screening, Day -1, Day 1, Day 8, and Day 36 of each treatment period.<br><br>Vitals: All visit days<br><br>Safety blood sampling: Screening, Day -1, Day 8, and Day 36 of each treatment period.<br><br>Suicidal ideation assessments: Screening and Day 8 of each treatment period.<br><br>Adverse event and concomitant medications will be reviewed at all visits from the time the subject signs consent to End of Study]