None listed
Conditions
Brief summary
This study is designed as a Phase I 'proof-of-concept' study designed to determine the pharmacokinetic and pharmacodynamic profile of a dose of midazolam to induce conscious sedation, when administered in healthy adults using the NasoSURF device, compared to intravenous administration.
Interventions
Each participant will be randomly allocated to a sequence to receive during each study period either a single dose of the intervention treatments or the comparator treatment in a two-way crossover sequence.
Intervention:
Treatment B: Midazolam 2.5 mg/kg (500 µL of 5mg/mL solution) delivered as a single dose intranasally using the NasoSURF Med device
Administration:
500µL of 5mg/mL midazolam solution for injection (effective dose 2.5mg) will be administered intranasally using the NasoSURF devic
Each participant will be randomly allocated to a sequence to receive during each study period either a single dose of the intervention treatments or the comparator treatment in a two-way crossover sequence. Intervention: Treatment B: Midazolam 2.5 mg/kg (500 µL of 5mg/mL solution) delivered as a single dose intranasally using the NasoSURF Med device Administration: 500µL of 5mg/mL midazolam solution for injection (effective dose 2.5mg) will be administered intranasally using the NasoSURF device (using continuous delivery mode – 0 Hz) into alternating nostrils over up to approximately 4 - 6 breath cycles. Participants will hold the device to self-administer while under nurse or doctor supervision. The nose-piece of the device will be inserted gently into one nostril at a time, and participants will exhale into the mouthpiece. Upon exhalation into the mouthpiece, the device will aerosolize the midazolam and administer ~125 µL of midazolam per breath-cycle via the nose-piece. The participant should alternate nostrils for each breath-cycle until all of the midazolam in the medicine unit of the device has been administered. During administration of midazolam with the NasoSURF device the participant’s head must be positioned in a straight and upright position. The time of administration will be documented. There will be a washout period of at least 48 hours between treatment periods.
Sponsors
AFT Pharmaceuticals Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Partipicants may be eligible for this study if they meet the following inclusion criteria • Male and female volunteers aged between 18 and 60 years, inclusive, on the day of consent. • Voluntarily provide written informed consent before the initiation of any study-related procedures. • Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m2. • Have no significant disease (cardiac, pulmonary, GI, hepatic, renal, haematological, neurological (including sleep disorders), infective, or psychiatric) as determined by medical history, physical examination and laboratory tests as determined by the Principal Investigator. • Be able and willing to abstain from caffeine-containing beverages (e.g. coffee, soda, or tea), caffeine-containing food (e.g. chocolate), and alcohol for 24 hours prior to study drug administration until after the last study sample is collected in each dosing period. • Be able and willing to abstain from all prescription and over-the-counter medications (excluding the study drug and oral contraceptive) and herbal medicines/supplements for the duration of the study as determined by the Principal Investigator. • Have a normal 12-lead ECG or one with an abnormality considered to be clinically insignificant as determined by the Principal Investigator.
Exclusion criteria
Participants will not be eligible for inclusion in this study if any of the following criteria are met: • Women who are pregnant or nursing. • Women of childbearing potential who are unwilling to take adequate contraceptive precautions, i.e., a hormonal contraceptive, an intrauterine device, double-barrier method, or abstinence. A woman of childbearing potential is defined as any female who is less than 2 years post-menopausal or has not undergone a partial or total hysterectomy or surgical sterilisation, e.g. bilateral tubal ligation, bilateral oophorectomy. • Women of childbearing potential who are unwilling to undergo a urine pregnancy test. • Have an alcohol intake in excess of 14 units per week for females and 21 units per week for males. • Have a history of drug abuse or positive test results for drug abuse. • Is a current smoker. • Have used prescription drugs (not including oral contraceptives) within 14 days prior to study drug administration or have used over-the-counter drugs, herbal products/supplements, or vitamins within 14 days prior to study drug administration, unless the Principal Investigator and Sponsor agree that the product taken will not impact on study conduct, results or participant safety. • Currently, or in last 30 days, participating in a clinical trial involving another study drug • Have donated blood or blood products within 30 days prior to study drug administration • Have a clinically significant abnormal laboratory test (as determined by the Principal Investigator) • Suffering from any other diseases or condition which, in the opinion of the investigator, means that the participant is unsuitable for the study. • Have previously undergone nasal surgery or experienced nasal trauma (including broken nose). • Midazolam Contraindications: Have a hypersensitivity to benzodiazepines, acute narrow angle glaucoma, or myasthenia gravis.
Outcome results
None listed