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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12622000952741

Enrollment

Registered

2022-07-06

Start date

2022-09-26

Completion date

2022-10-04

Last updated

2022-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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 will perform a disintegration check 10 minutes after administration.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Yes

Inclusion criteria

1. Good general health. 2.. Willing and able to provide informed consent for study participation. 3. Has suitable venous access for blood sampling. 4. Body weight a minimum of 50 kg and BMI within the range of 19.0-28.0 kg/m2 (inclusive).

Exclusion criteria

1. 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. 2. Presence or history of malignancy (exception: successfully treated basal cell carcinoma is not an exclusion). 3. Clinically significant abnormal 12-lead ECG or history of clinically significant cardiac dysrhythmias, including bradycardia. 4. Clinically significant orthostatic vital signs at screening or vital signs on admission day.

Outcome results