Neuropathic pain
Conditions
Interventions
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 investig
Sponsors
Celtic Pharma Development Services Europe Ltd.
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Netherlands
Outcome results
None listed