A programme to develop a skin patch containing two medicines (physostigmine and hyoscine) - study 2: Assessment of blood levels of the two medicines and any associated symptoms in healthy male participants wearing four prototype skin patches

Phase 1

Completed

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

• Registration Number: ISRCTN29062676
• Lead Sponsor: Defence Science and Technology Laboratory (Dstl)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2006-05-30
• Study Start: 2019-09-06
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 24

Inclusion Criteria

Subjects had to meet all of the following 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 ? 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

Exclusion Criteria

1. Presence of any clinically significant medical condition as determined by the Investigator
2. Any surgical or medical condition which might have significantly altered 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 other than sinus bradycardia or respiratory sinus arrhythmia
4. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the study products
5. Any history of contact dermatitis
6. Plasma cholinesterase genotype homozygous for A or S variant
7. Any skin disorder, broken skin, scars, tattoos at the sites of patch application (i.e. on both arms)
8. Glaucoma or a history of glaucoma in first degree relatives (i.e. parents, siblings or offspring)
9. Presence of Anterior Chamber Narrow Angle (Van Herrick Grade 1 and 2)
10. Intra-ocular pressure exceeding 20 mm Hg
11. Uncorrected vision in both eyes of worse than 6/9 on the Snellen Scale
12. Required glasses or contact lenses for distance vision
13. Peripheral visual fields outside of age corrected normal parameters
14. History of asthma (within the previous 10 years), exercise induced bronchospasm or relevant seasonal bronchospasm
15. Lung function of less than 80% of predicted spirometry criteria
16. History or evidence of drug abuse (opiates, methadone, cocaine, amphetamines, methamphetamines, cannabinoids, 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 three months prior to Screening
21. Use of any prescription medication within 21 days prior to Baseline
22. Use of non-prescription medication within 7 days prior to Baseline (apart from paracetamol)
23. Donation of blood or blood products for a period of 3 months prior to or the intention to donate blood or blood products within 3 months after completion of the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of physostigmine/hyoscine combination measured using safety monitoring, blood sampling for pharmacokinetics and pharmacodynamics, patch adhesion and patch application site assessments, ECG and ocular function assessments were performed for up to 96 hours after the application of each patch