A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 7: Assessment of effects of an armband covering the skin patch on the blood levels of the two medicines and any associated symptoms in healthy male participants

Phase 2

Completed

• Conditions: Potential risk of poisoning by nerve agent; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN13607674
• Lead Sponsor: Defence Science and Technology Laboratory

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2011-02-15
• Study Start: 2021-01-11
• Last Update Posted: 18 January 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 31

Inclusion Criteria

1. Ability to give written informed consent prior to study participation
2. Healthy Caucasian male subjects aged between 18 and 40 years (inclusive)
3. Body Mass Index (BMI) within the range of =21 and =29 kg/m²
4. Vital signs within the following ranges:
4.1. Heart 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

Exclusion Criteria

Screening:
1. Presence of any clinically significant medical condition as determined by the Investigator
2. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or
liver disease, respiratory, immunological, endocrine or neurological disorders)
3. Any ECG abnormality considered to be clinically significant i.e. baseline prolongation of QT/QTc interval >450 ms or history of additional risk factors for Torsade de Point (heart failure, hypokalemia, family history of Long QT Syndrome)
4. Known or suspected hypersensitivity or idiosyncratic reaction to any of the study products
5. A dibucaine number of less than 70
6. History of asthma (within the previous 10 years), exercise induced bronchospasm or relevant seasonal bronchospasm
7. Lung function of less than 80% of predicted FEV1 and FVC
8. Any history of contact dermatitis
9. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both arms)
10. Glaucoma or a history of glaucoma in first-degree relatives (i.e. parents, siblings or offspring)
11. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
12. Intra-ocular pressure exceeding 20 mmHg
13. Uncorrected vision in both eyes of worse than 6/9 on the Snellen Scale
14. Corrected vision of 6/9 or better on the Snellen Scale when wearing +2.25 dioptre reading glasses
15. Required glasses or contact lenses for distance vision
16. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, cannabinoids or barbiturates)
17. Positive test for HIV, hepatitis B or hepatitis C
18. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (4 units per day), where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine
19. Positive urine test for alcohol
20. Participation in another clinical study within the last three months
21. Use of any prescription medication within the last 14 days
22. Use of non-prescription medication (apart from paracetamol) within the last seven days that may have an impact on the safety and objectives of the study (at the Investigator’s discretion)
23. Donation of blood or blood products within the last three months, or the intention to donate blood or blood products within three months after completion of the study

Baseline (all periods):
1. Development of any exclusion criteria since last visit
2. Positive urine test for alcohol
3. Positive drugs of abuse test
4. Use of any prescription medication since last visit (with the exception of hormonal contraception)
5. Use of non-prescription medication that may impact the safety aspects and objectives of the study, within the last seven days (apart from paracetamol)

Study & Design

• Study Type: Interventional
• Study Design: Not specified