nderstanding the profile of midazolam administered using the NasoSURF device to healthy volunteers

Phase 1

• Conditions: Conscious Sedation; Anaesthesiology - Other anaesthesiology

• Registration Number: ACTRN12621001427864
• Lead Sponsor: AFT Pharmaceuticals Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-10-21
• Last Update Posted: 3 October 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified