The purpose of the study is to investigate how quickly and to what extent rivastigmine is absorbed and eliminated from the body when administered RTS for 7 days (this is called pharmacokinetics) as well as the safety of RTS.
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pharmacokinetics: plasma concentrations and PK parameters
Dermal evaluations, patch adhesion, amount of adhesive residue application
site, difficulty of patch removal, residual drug
analysis
Safety: AEs, vital signs, ECG, clinical laboratory assessments, physical
examination
Secondary outcome
nvt
Background summary
The 7-day rivastigmine transdermal system (RTS) is a new, investigational
transdermal application form (transdermal means: patch for administration via
the skin) of the known drug rivastigmine that may eventually be used for the
treatment of mild to moderate Alzheimer*s disease related dementia and
Parkinson*s disease related dementia. Rivastigmine blocks the degradation of
acetylcholine, a compound involved in signal transduction between nervous cells
decreasing the symptoms of dementia. The 7-day RTS being studied will be worn
for 7 continuous days and has not been registered as an administration form.
Rivastigmine has been given to humans using a transdermal patch before. The
Exelon® transdermal patch contains rivastigmine is worn for 24 hours, and is a
registered drug.
Study objective
The purpose of the study is to investigate how quickly and to what extent
rivastigmine is absorbed and eliminated from the body when administered RTS for
7 days (this is called pharmacokinetics) as well as the safety of RTS.
Study design
The study will consist of 3 periods during which you will stay in the clinical
research center in Zuidlaren for 10 days (9 nights) for each period. The time
interval between the different periods is at least 5 days between leaving the
clinical research center and entering the clinical research center for the next
period. Your participation to the entire investigation, from pre-study
screening to post study screening, will be maximally 73 days.
For each period you are expected at the clinical research center at 14:00 h in
the afternoon prior to the day of drug administration. You will be required not
to have consumed any food or drinks during the 4 hours prior to arrival in the
clinical research center (with the exception of water).
You will leave the clinical research center on Day 9 of each period (Day 1 is
the day of study drug administration).
7 to 10 days after discharge from the clinical research center after Period 3,
you will be called for a short update.
Intervention
On Day 1 of each period RTS or Exelon® will be applied after a fasting period
(no food or drinks) of at least 10 hours. The transdermal patches will be
applied to your upper back. Per period you will receive 1 of the treatments.
During the study you will receive all 3 treatments once. The sequence of the
treatments will be determined by chance.
The Exelon® patch will be removed every morning and a new patch will be applied
to a different site on your back. In the morning of Day 8 the (last) patch will
be removed.
On Day 7 of each period you will also have to remain fasted for 10 hours before
the time of application.
For all groups the fasting period on Day 1 and 7 will continue until 4 hours
after the time of drug administration. Then you will receive a lunch. During
fasting and after application of the study medication, you are allowed to drink
water with the exception of 1 hour prior to until 1 hour after the time of drug
administration.
Study burden and risks
Procedures: pain, light bleeding, heamatoma, possibly an infection.
Rivastigmine has been on the market since 1998. Transdermal patches containing
rivastigmine have been on the market from 2006 onwards. The 7-day RTS will be
applied to humans for the first time in this study, as a result to date adverse
effects in humans have not been reported.
Common side effects associated with the use of a transdermal system may
include, but are not limited to, local skin irritation of the patch site
(including redness, itching, or rash). The most common side effects of
rivastigmine are nausea, vomiting, and diarrhea. Other side effects that are
not as common are tremors, anorexia and dizziness.
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US
Listed location countries
Age
Inclusion criteria
healthy male and female subjects
18-65 yrs, inclusive
BMI: 18.0-29.9 kg/m2, inclusive
non-smoking
light skin color
Exclusion criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 60 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-000989-11-NL |
| CCMO | NL44242.056.13 |