Part 1A:Primary objective is to evaluate the safety and tolerability of ascending single doses of TDT 077 in healthy older male and female subjects. Secondary objective is to evaluate the systemic exposure (PK) of ascending single doses of TDT 077…
ID
Source
Brief title
Condition
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Part 1A:
Primary objective is to evaluate the safety and tolerability of ascending
single doses of TDT 077 in healthy older male and female subjects.
Part 1B:
To validate the sensitivity of the clinical methods for the assessment of
analgesia and anaesthesia.
Part 2:
Primary objective is to evaluate the safety and tolerability of ascending
multiple doses of TDT 077 in healthy older male and female subjects.
Secondary outcome
Part 1A:
Secondary objective is to evaluate the systemic exposure (PK) of ascending
single doses of TDT 077 in healthy older male and female subjects. The third
objective is to evaluate the magnitude and duration of effect (analgesia and
anaesthesia) of ascending single doses of TDT 077 in older male and female
subjects.
Part 1B:
Not applicable
Part 2:
Secondary objective is evaluate the systemic exposure (PK) of ascending
multiple doses of TDT 077 in healthy older male and female subjects. Third
objective is to evaluate the magnitude and duration of effect (analgesia and
anaesthesia) of ascending multiple doses of TDT 077 in healthy older male and
female subjects.
Background summary
TDT 077 is an investigational product, which is being developed to reduce pain
as a result of e.g. diabetes, HIV/AIDS and shingles. It is a combination of
bupivacaine (a pain reducer) and Transfersomes®. When TDT 077 is applied to the
skin, bupivacaine is transported to the target area by Transfersomes®. There,
bupivacaine will bind to the nerve cell (a cell is the smallest unit of which
the body consist of, a nerve cell is important for passing through pain
signals). Bupivacaine reduces the permeability of the cell. By doing this, the
conductivity of the cell is being reduced and thus the pain signals, which pass
through by this cell.
Emla® cream is marketed for the indication local anaesthesia of the skin and
will only be applied in part 1B of this study.
One gram of Emla® cream contains 25 mg of lidocaine and 25 mg of prilocaine
(both aneasthetics). It works in the same manner as bupivacaine (as described
above).
Study objective
Part 1A:
Primary objective is to evaluate the safety and tolerability of ascending
single doses of TDT 077 in healthy older male and female subjects. Secondary
objective is to evaluate the systemic exposure (PK) of ascending single doses
of TDT 077 in healthy older male and female subjects. The third objective is to
evaluate the magnitude and duration of effect (analgesia and anaesthesia) of
ascending single doses of TDT 077 in older male and female subjects.
Part 1B:
To validate the sensitivity of the clinical methods for the assessment of
analgesia and anaesthesia.
Part 2:
Primary objective is to evaluate the safety and tolerability of ascending
multiple doses of TDT 077 in healthy older male and female subjects. Secondary
objective is evaluate the systemic exposure (PK) of ascending multiple doses of
TDT 077 in healthy older male and female subjects. Third objective is to
evaluate the magnitude and duration of effect (analgesia and anaesthesia) of
ascending multiple doses of TDT 077 in healthy older male and female subjects.
Study design
Part 1A:
6 groups of 8 healthy males and females will participate in this part of the
trial.
For groups 1-5 the trial consist of a medical screening, an admission period of
5 days, a short visit and a follow up.
For group 7 the trial consists of a medical screening, an admission period of 3
days, a short visit and a follow up
Part 1B:
1 group of 8 healthy males and females will participate in this part of the
trial. This part of the trial consist of a medical screening and an admission
period of 2 days.
Part 2:
5 groups of 8 healthy males and females will participate in this part of the
trial. This part of the trial consist of a medical screening, an admission
period of 18 days, 10 short visits and a follow up.
Intervention
In Part 1A of this study (KNL40862) the investigational product will be applied
once.
In Part 1B of this study (KNL40862) EMLA will be applied once.
In Part 2 of this study (KNL 40863) the investigational product will be applied
twice a day on days 1 to 13 and once a day on day 14.
Study burden and risks
The risks for the volunteers participating in this trial are related to the
possible side effects of the investigational product and EMLA. Next, the
inconvenience for the volunteer depends on the duration of the admission
period, venapunctures and inserting the cannula. All volunteers will be closely
monitored by experienced physicians and other staff.
Leverton House, 13 Bedford Square
London WC1B 3RA
United Kingdom
Leverton House, 13 Bedford Square
London WC1B 3RA
United Kingdom
Listed location countries
Age
Inclusion criteria
• Subjects must voluntarily sign a written informed consent agreement;
• Age 55-75 years except cohort 6B. Age 18-40 for cohort 6B;
• Female subjects should be of non-childbearing potential (surgically sterile or more than 1 year post-menopausal) or if of childbearing potential must be using a medically acceptable form of birth control for the duration of the study;
• Male subjects: you are not able to cause a pregnancy or uses a medically acceptable form of birth control for th duration of the study;
• Subjects must be in good health;
• Body Mass Index (BMI) between 18 and 30 (inclusive), with body weight greater than or equal to 60 kg and less than or equal to 100 kg;
• No clinically significant abnormalities at screening
Exclusion criteria
• Subjects with a known hypersensitivity or allergy to bupivacaine, other local anaesthetics or to any of the excipients in TDT 077 (Part 1A and Part 2);
• Subjects with a known hypersensitivity or allergy to lidocaine and/or prilocain, other local anaesthetics or to any of the excipients in EMLA® hydrophilic cream (Part 1B);
• Subject has any skin irritation or disease that might interfere with absorption of study drug or skin irritation assessment, including eczema, psoriasis, melanoma;
• Subjects with active presence or history of alcoholism or drug addiction;
• Subject has a tattoo or other skin deformities that might interfere with skin irritation assessment;
• Subject has had a surgery within the last 3 months prior to dosing;
• Female subjects that are pregnant or lactating;
• Subjects who have used prescription medication within two weeks prior to the first dosing day, except for contraceptives or HRT;
• Subjects who have used over-the-counter medication (including homeopathic medicines and vitamins), within 96 hours prior to the dosing day;
• Subjects who have been treated with other local anaesthetic therapy within 3 weeks prior to dosing;
• Subjects who smoke more than 10 cigarettes per day and who are unable to abstain from smoking when at the study centre;
• Subjects who participated in an investigational drug study within 3 months prior to the dosing day;
• Subjects who have lost or donated >350 ml of blood within 12 weeks prior to the screening session;
• Subjects who test positive for HBsAg, Anti-HCV or HIV;
• Subjects with a relevant food or drug hypersensitivity or allergy;
• Subjects who are considered unsuitable to participate in the study for any reason in the opinion of the principal investigator.
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 | EUCTR2007-006781-15-NL |
| CCMO | NL20901.040.07 |