A programme to develop a skin patch containing two medicines (physostigmine and hyoscine), Study 1: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing prototype skin patches

Phase 1

Completed

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

• Registration Number: ISRCTN21827000
• Lead Sponsor: Dstl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2004-12-13
• Study Start: 2019-07-30
• Last Update Posted: 26 August 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 18

Inclusion Criteria

1. Healthy male participants
2. Aged between 18 and 40 years inclusive
3. Body Mass Index (BMI) = 18 and = 31 kg/m2, and body weight = 60 and = 110 kg
4. Able to understand the informed consent discussion, which included information about potential risks and effects of the test materials, and signed the informed consent form
5. Medical history without major pathology (e.g. cardiac, immunological, endocrine or neurological disorders, cancer or other wasting diseases)
6. Human immunodeficiency virus (HIV), hepatitis B and hepatitis C negative
7. No clinically significant abnormalities at the pre-study screening, and subject’s GP had not advised against inclusion
8. Computerised 12-lead ECG recording without clinically relevant signs of pathology and conductance disturbances as judged by the investigator

Exclusion Criteria

1. Presence of any clinically significant medical condition as determined by the investigator
2. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the test materials
3. Homozygous or heterozygous for the atypical (dibucaine resistant) allele of butyrylcholinesterase
4. Any skin disorder, broken skin, scars, tattoos at the site of application
5. Glaucoma or a history of glaucoma in first degree relatives (i.e. parents, siblings and offspring)
6. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
7. Intra-ocular pressure exceeding 20 mm Hg
8. Uncorrected vision (or contact lens corrected vision) in either eye worse than 6/9 on the Snellen scale
9. History or evidence of drug abuse (including opiates, methadone, cocaine, amphetamines, cannabinoids, barbiturates)
10. History or evidence of alcohol abuse defined as intake of more than 21 units per week (3 units per day), where 1 unit corresponds to 250 mL beer, 20 mL spirits/liqueur or one glass (100 mL) of wine
11. Participation in another clinical trial within three months prior to the start of the study
12. Use of any prescription medication within two weeks, or non-prescription medication (e.g. acetylsalicylic acid/paracetamol) within 48 hours, prior to dosing
13. Regular drug intake during the month prior to the start of the study
14. History or suspicion of inability to co-operate adequately
15. Donation of blood or blood products for a period of four weeks prior to and four weeks after completion of the study
16. History of asthma (or history of asthma within the previous 10 to 15 years, at investigator’s discretion)
17. History of exercise-induced bronchospasm, or relevant seasonal bronchospasm
18. Lung function (FEV1) less than 80% of predicted spirometry criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified