Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

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

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.

Study Overview

• Status: Unknown
• Conditions: Sedation
• Intervention / Treatment: Drug: Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Drug: Intravenous Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China
      • Recruiting
      • The third xiangya hospital of Central South University
      • Contact: Jie Huang; Phone Number: 15116469024; Email: cellahuang1988@163.com
      • Principal Investigator: Guoping Yang, PhD
      • Principal Investigator: Wen Ouyang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: A1; 20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8	Drug: Intranasal Dexmedetomidine; Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Intranasal Placebo; Drug: Intravenous Placebo; Intravenous Placebo
EXPERIMENTAL: A2; 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8	Drug: Intranasal Dexmedetomidine; Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Intranasal Placebo; Drug: Intravenous Placebo; Intravenous Placebo
EXPERIMENTAL: B1; 40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8	Drug: Intranasal Dexmedetomidine; Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Intranasal Placebo; Drug: Intravenous Placebo; Intravenous Placebo
EXPERIMENTAL: B2; 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8	Drug: Intranasal Dexmedetomidine; Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Intranasal Placebo; Drug: Intravenous Placebo; Intravenous Placebo
EXPERIMENTAL: C; 80µg Dexmedetomidine or Placebo is administered intranasally on Day 1	Drug: Intranasal Dexmedetomidine; Intranasal Dexmedetomidine; Drug: Intranasal Placebo; Intranasal Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 26, 2017
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): July 1, 2018

Study Registration Dates

• First Submitted: August 23, 2017
• First Submitted That Met QC Criteria: September 24, 2017
• First Posted (ACTUAL): September 26, 2017

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2018
• Last Update Submitted That Met QC Criteria: January 18, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Dexmedetomidine
• Other Study ID Numbers: HR0171401-101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No