Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

Study Overview
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Brief Summary
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The aim of this study is to investigate the safety, pharmacokinetics, pharmacodynamics of intranasal dexmedetomidine, and comparative pharmacokinetics of intranasally and intravenously administered dexmedetomidine in healthy volunteers.

Official Title
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A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

Conditions
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Sedation

Intervention / Treatment
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* Drug: Intranasal Dexmedetomidine
* Drug: Intravenous Dexmedetomidine
* Drug: Intranasal Placebo
* Drug: Intravenous Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult male 18 - 40 years of age Body weight >/= 50 kg (male) or >/= 45 kg (female), with BMI between 19.0 and 26.0 kg/m2, inclusive Capable of giving written informed consent Exclusion Criteria: Clinically significant disease or conditions that may place the subject at unacceptable risk as a participant in the study, or that may interfere with the safety, tolerability or pharmacodynamic evaluations in the study Laboratory tests positive for HIV, Hepatitis B virus surface antigen, or Hepatitis C virus antibody; positive drug or alcohol test Major surgery within 4 weeks of screening

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A1<br>20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 | Drug: Intranasal Dexmedetomidine<br>* Intranasal Dexmedetomidine<br>Drug: Intravenous Dexmedetomidine<br>* Intravenous Dexmedetomidine<br>Drug: Intranasal Placebo<br>* Intranasal Placebo<br>Drug: Intravenous Placebo<br>* Intravenous Placebo<br>|
| Experimental: A2<br>20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8 | Drug: Intranasal Dexmedetomidine<br>* Intranasal Dexmedetomidine<br>Drug: Intravenous Dexmedetomidine<br>* Intravenous Dexmedetomidine<br>Drug: Intranasal Placebo<br>* Intranasal Placebo<br>Drug: Intravenous Placebo<br>* Intravenous Placebo<br>|
| Experimental: B1<br>40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 | Drug: Intranasal Dexmedetomidine<br>* Intranasal Dexmedetomidine<br>Drug: Intravenous Dexmedetomidine<br>* Intravenous Dexmedetomidine<br>Drug: Intranasal Placebo<br>* Intranasal Placebo<br>Drug: Intravenous Placebo<br>* Intravenous Placebo<br>|
| Experimental: B2<br>40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8 | Drug: Intranasal Dexmedetomidine<br>* Intranasal Dexmedetomidine<br>Drug: Intravenous Dexmedetomidine<br>* Intravenous Dexmedetomidine<br>Drug: Intranasal Placebo<br>* Intranasal Placebo<br>Drug: Intravenous Placebo<br>* Intravenous Placebo<br>|
| Experimental: C<br>80µg Dexmedetomidine or Placebo is administered intranasally on Day 1 | Drug: Intranasal Dexmedetomidine<br>* Intranasal Dexmedetomidine<br>Drug: Intranasal Placebo<br>* Intranasal Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Number of subjects with adverse events | Baseline to 7 days after dose administration |