Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Sedation

Treatments: Drug: Intranasal Dexmedetomidine; Drug: Intranasal Placebo; Drug: Intravenous Placebo; Drug: Intravenous Dexmedetomidine

Study type: Interventional

Funder types: Industry

Identifiers

NCT03293277

HR0171401-101

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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48 participants in 5 patient groups

A1

Experimental group

Description:

20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8

Treatment:

Drug: Intravenous Placebo

Drug: Intravenous Dexmedetomidine

Drug: Intranasal Placebo

Drug: Intranasal Dexmedetomidine

A2

Experimental group

Description:

20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8

Treatment:

Drug: Intravenous Placebo

Drug: Intravenous Dexmedetomidine

Drug: Intranasal Placebo

Drug: Intranasal Dexmedetomidine

B1

Experimental group

Description:

40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8

Treatment:

Drug: Intravenous Placebo

Drug: Intravenous Dexmedetomidine

Drug: Intranasal Placebo

Drug: Intranasal Dexmedetomidine

B2

Experimental group

Description:

40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8

Treatment:

Drug: Intravenous Placebo

Drug: Intravenous Dexmedetomidine

Drug: Intranasal Placebo

Drug: Intranasal Dexmedetomidine

C

Experimental group

Description:

80µg Dexmedetomidine or Placebo is administered intranasally on Day 1

Treatment:

Drug: Intranasal Placebo

Drug: Intranasal Dexmedetomidine