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

Phase 1

Completed

• Conditions: Agitation; Mental Health - Anxiety

• Registration Number: ACTRN12622000952741
• Lead Sponsor: iX Biopharma Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-07-06
• Study Completion: 2022-10-08
• Last Update Posted: 14 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the pharmacokinetics effects of different dosages of dexmedetomidine wafers administered via sublingual route vs. intravenous dexmedetomidine. Standard non-compartmental analysis methods will be used to obtain PK variables for dexmedetomidine such as Cmax, AUCinf, CL, Tmax, Cmax, Vz, and t1/2.[Pharmacokinetic blood samples will be collected pre-dose and at 5, 10, 15, 20, 30, 40, 50 mins and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 hours post dose.]