A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 3: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing four prototype skin patches.
Phase 2
Completed
- Conditions
- Potential risk of poisoning by nerve agentInjury, Occupational Diseases, Poisoning
- Registration Number
- ISRCTN16859029
- Lead Sponsor
- Defence Science and Technology Laboratory (Dstl)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
At screening for period 1:
1. Ability to give written informed consent prior to study participation
2. Healthy Caucasian male participants aged between 18 and 45 years (inclusive)
3. Body Mass Index (BMI) within the range of 21 and 30 kg/m2
4. Vital signs within the following ranges:
4.1 Pulse rate 40-90 bpm
4.2 Systolic blood pressure 90-140 mmHg
4.3 Diastolic blood pressure 50-90 mmHg
5. Ability to communicate well with the Investigator and to comply with the requirements of the study.
Baseline (Period 2):
1. Successful completion of Part 1.
2. Randomisation to take part in Part 2.
3. Willing and able to continue in the study.
Exclusion Criteria
Does not meet inclusion criteria
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety and tolerability of drugs tested was assessed by monitoring vital signs, ECG, near point ocular function and patch application site assessment using digital photography. In period 1 these parameters were measured at baseline and at pre-determined intervals up to 84 hours after patch application, prior to discharge on day 5 and at follow up. In period 2 they were measured at these times and also at additional time points up to follow up at Day 42 after the first patch application
- Secondary Outcome Measures
Name Time Method <br> 1. Pharmacokinetic measures:<br> Plasma concentration of physostigmine and hyoscine tested at following intervals. Period 1: pre-dose and at intervals up to 96 hrs after the patch application. Period 2: pre-dose and at intervals up to 240 hours after application of the first patch. (test method for PK measures was liquid chromatography tandem mass spectrometry (LC-MS-MS) method).<br> 2. Pharmacodynamic measures:<br> Blood measurement of red cell acetylcholinesterase (AChE) activity tested at the following intervals. Period 1: pre-dose and at intervals up to 96 hrs after the patch application. Period 2: pre-dose and at intervals up to 240 hours after application of the first patch. (test method for PK measures was validated spectrophotometric method).<br>