Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

Phase 1

• Conditions: Sedation
• Interventions: Drug: Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Drug: Intravenous Placebo

• Registration Number: NCT03293277
• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-26
• Study First Submitted: 2017-08-23
• Study First Submitted QC: 2017-09-24
• Study First Posted: 2017-09-26
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-18
• Last Update Posted: 2018-01-23
• Primary Completion: 2018-07
• Study Completion: 2018-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B1	Intravenous Dexmedetomidine	40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
B1	Intranasal Dexmedetomidine	40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
C	Intranasal Dexmedetomidine	80µg Dexmedetomidine or Placebo is administered intranasally on Day 1
A2	Intravenous Dexmedetomidine	20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
A1	Intravenous Dexmedetomidine	20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
A1	Intranasal Dexmedetomidine	20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
A2	Intranasal Placebo	20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
A2	Intravenous Placebo	20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
B2	Intranasal Placebo	40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
A1	Intranasal Placebo	20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
A1	Intravenous Placebo	20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
A2	Intranasal Dexmedetomidine	20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8
B2	Intravenous Dexmedetomidine	40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
C	Intranasal Placebo	80µg Dexmedetomidine or Placebo is administered intranasally on Day 1
B1	Intranasal Placebo	40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8
B2	Intranasal Dexmedetomidine	40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
B2	Intravenous Placebo	40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8
B1	Intravenous Placebo	40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8

Primary Outcome Measures

Name	Time	Method
Adverse Events	Baseline to 7 days after dose administration	Number of subjects with adverse events

Trial Locations

Locations (1)

The Third Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China