CompletedPhase 1ACTRN12622000952741

A study testing wafers containing different doses of dexmedetomidine in healthy volunteers.

An open label, four-way crossover study to evaluate the pharmacokinetic effects of different dosages of a novel sublingual dexmedetomidine wafer compared to intravenous dexmedetomidine, in healthy volunteers under fasted conditions.

Sponsor

iX Biopharma Pty Ltd

Enrollment

14 participants

Start Date

Sep 26, 2022

Study Type

Interventional

Conditions

Agitation

Summary

This is an open-label, four-way crossover, fasted pharmacokinetic study in healthy volunteers. The screening visit will include a physical exam, vital signs collection, an electrocardiogram, safety laboratory sampling and urinalysis to determine suitability for inclusion into the study. Qualified study participants will be admitted the evening prior (Day -1) to scheduled dosing. Each participant will receive a single dose of study medication per dosing day. There will be a minimum washout of 44 hours between doses. Participants will remain inpatient for the entire dosing/washout period and will be discharged 24 hours after Treatment D.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 65 Yearss

Inclusion Criteria4

Good general health.
Willing and able to provide informed consent for study participation.
Has suitable venous access for blood sampling.
Body weight a minimum of 50 kg and BMI within the range of 19.0-28.0 kg/m2 (inclusive).

Exclusion Criteria4

History of or current serious, clinically significant, or unstable medical condition which, in the opinion of the Investigator, could affect safety or integrity of study results.
Presence or history of malignancy (exception: successfully treated basal cell carcinoma is not an exclusion).
Clinically significant abnormal 12-lead ECG or history of clinically significant cardiac dysrhythmias, including bradycardia.
Clinically significant orthostatic vital signs at screening or vital signs on admission day.

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Interventions

Participants will receive a single dose of sublingual dexmedetomidine wafer 30, 50 and 100mcg, with a minimum washout of 44 hours between each dose. Administration under clinical monitoring. Staff w

Participants will receive a single dose of sublingual dexmedetomidine wafer 30, 50 and 100mcg, with a minimum washout of 44 hours between each dose. Administration under clinical monitoring. Staff will perform a disintegration check 10 minutes after administration.