Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects

NCT03293277 | Unknown Phase 1

• 1 other identifier: HR0171401-101
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Sedation

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of subjects with adverse events

  Baseline to 7 days after dose administration

Study Arms (5)

A1

EXPERIMENTAL

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

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

A2

EXPERIMENTAL

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

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

B1

EXPERIMENTAL

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

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

B2

EXPERIMENTAL

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

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

C

EXPERIMENTAL

80µg Dexmedetomidine or Placebo is administered intranasally on Day 1

Drug: Intranasal Dexmedetomidine; Drug: Intranasal Placebo

Interventions

Intranasal Dexmedetomidine DRUG

Intranasal Dexmedetomidine

A1; A2; B1; B2; C

Intravenous Dexmedetomidine DRUG

Intravenous Dexmedetomidine

A1; A2; B1; B2

Intranasal Placebo DRUG

Intranasal Placebo

A1; A2; B1; B2; C

Intravenous Placebo DRUG

Intravenous Placebo

A1; A2; B1; B2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, China

RECRUITING

Central Study Contacts

Shirley Cai, MD

CONTACT

18036618138; caixiaoli@shhrp.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2017
• First Posted: September 26, 2017
• Study Start: July 26, 2017
• Primary Completion: July 1, 2018
• Study Completion: July 1, 2018
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

CN (1)