SedationPhase 1NCT03293277
Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
A Phase 1 study testing Intranasal Dexmedetomidine and Intravenous Dexmedetomidine in people with Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedation
- What is being tested?
- Intranasal Dexmedetomidine and Intravenous Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteChina
- Study dates
- 26 Jul 2017to Jul 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Jie Huang, 15116469024, cellahuang1988@163.com
Guoping Yang, PhD
About this study
Official title: 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.
- Conditions
- Sedation
- Being tested
- Intranasal Dexmedetomidine, Intravenous Dexmedetomidine, Intranasal Placebo, Intravenous Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal DexmedetomidineDrug
Intranasal Dexmedetomidine
Intravenous DexmedetomidineDrug
Intravenous Dexmedetomidine
Intranasal PlaceboDrug
Intranasal Placebo
Intravenous PlaceboDrug
Intravenous Placebo
| Study group | Role | What they receive |
|---|---|---|
| A1 | Experimental | 20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 Receives: 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 Receives: 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 Receives: 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 Receives: Drug: Intranasal Dexmedetomidine; Drug: Intravenous Dexmedetomidine; Drug: Intranasal Placebo; Drug: Intravenous Placebo |
| C | Experimental | 80µg Dexmedetomidine or Placebo is administered intranasally on Day 1 Receives: Drug: Intranasal Dexmedetomidine; Drug: Intranasal Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Number of subjects with adverse events
Measured: Baseline to 7 days after dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start26 Jul 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedationStudies of the same condition, open and under way.
- More trials run by Jiangsu HengRui Medicine Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293277
- Sponsor's protocol ID
- HR0171401-101
- Status last verified
- Jan 2018
- First submitted
- 23 Aug 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Intranasal Dexmedetomidine in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03293277
- Acronym / sponsor ID
- HR0171401-101
- Conditions
- Sedation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Jiangsu HengRui Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| A1 | Experimental | Drug: Intranasal Dexmedetomidine, Drug: Intravenous Dexmedetomidine, Drug: Intranasal Placebo, Drug: Intravenous Placebo20µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 |
| A2 | Experimental | Drug: Intranasal Dexmedetomidine, Drug: Intravenous Dexmedetomidine, Drug: Intranasal Placebo, Drug: Intravenous Placebo20µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 20µg Dexmedetomidine or Placebo is administered intranasally on Day 8 |
| B1 | Experimental | Drug: Intranasal Dexmedetomidine, Drug: Intravenous Dexmedetomidine, Drug: Intranasal Placebo, Drug: Intravenous Placebo40µg Dexmedetomidine or Placebo is administered intranasally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intravenousally on Day 8 |
| B2 | Experimental | Drug: Intranasal Dexmedetomidine, Drug: Intravenous Dexmedetomidine, Drug: Intranasal Placebo, Drug: Intravenous Placebo40µg Dexmedetomidine or Placebo is administered intravenousally on Day 1, and 40µg Dexmedetomidine or Placebo is administered intranasally on Day 8 |
| C | Experimental | Drug: Intranasal Dexmedetomidine, Drug: Intranasal Placebo80µg Dexmedetomidine or Placebo is administered intranasally on Day 1 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal DexmedetomidineIntranasal Dexmedetomidine | Drug | A1, A2, B1, B2, C |
| Intravenous DexmedetomidineIntravenous Dexmedetomidine | Drug | A1, A2, B1, B2 |
| Intranasal PlaceboIntranasal Placebo | Drug | A1, A2, B1, B2, C |
| Intravenous PlaceboIntravenous Placebo | Drug | A1, A2, B1, B2 |
Primary outcome
Adverse Events
Time frame: Baseline to 7 days after dose administration
Number of subjects with adverse events
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Intranasal Dexmedetomidine and Intravenous Dexmedetomidine in people with Sedation, run by Jiangsu HengRui Medicine Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shirley Cai, MD (18036618138, caixiaoli@shhrp.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Events (time frame: Baseline to 7 days after dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2018.