The pharmacokinetics of intranasal droperidol in healthy volunteers.

Phase 4

Completed

• Conditions: Pharmacokinetics of intranasal drug delivery in healthy human volunteers.; Other - Research that is not of generic health relevance and not applicable to specific health categories listed above

• Registration Number: ACTRN12614000514606
• Lead Sponsor: Monash Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-15
• Study Completion: 2015-04-01
• Last Update Posted: 16 February 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Male
• Target Recruitment: 7

Inclusion Criteria

Healthy adult males aged between 18 and 55 years
Body weight > 50kg and < 100 kg with BMI < 28

Exclusion Criteria

Female gender
Allergy to droperidol
Previous history of any dystonic reaction to medications
Abnormal nasal anatomy
Previous nasal surgery or nasal trauma that may interfere with administration of absorption of intranasal medication
Current or recent upper respiratory tract infection
Use of any prescription or non-prescription drugs that may affect droperidol metabolism or nasal physiology (vasoconstrictors e.g. phenylephrine) within the past seven days
Treatment with medication known to prolong the QT interval
Absolute QT calculated as the average of three limb lead and three chest lead (V2-V4) QT interval duration.
Abnormal 12-lead ECG on screening with QTcorrected> 480 msec using Sagie regression QTc calculation formula and correlated with Isbister QT-heart rate pair nomogram.
Any known cardiovascular, gastrointestinal, pulmonary, renal, haematologic or liver disease
Any psychiatric or mental health disorder or previous history of antipsychotic medication use

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the pharmacokinetics of intranasal droperidol and to compare these with equivalent doses of intravenous droperidol administered to healthy volunteers. These will include peak serum droperidol concentration (Cmax), time to peak serum concentration (Tmax), terminal elimination half-life (t1/2), area under the time concentration curve (AUC).[Pharmacokinetic blood sampling at time 0, 15, 30, 60 minutes post-dosing and 2, 3, 4, 6, 8, 10 hours post-dosing.]

Secondary Outcome Measures

Name	Time	Method
Assess safety and tolerability of intranasal droperidol following a single low dose<br>Vital signs (blood pressure/heart rate/oxygen saturations/temperature)<br>Level of consciousness<br>Local adverse events: nasal irritation, bleeding, or any reported symptoms<br>Systemic adverse events<br>12-lead ECGs traces and QT-interval duration<br>[Subjects observed for 12 hours post-dosing for each study arm.]