HealthyPhase 1NCT01451229
Pharmacokinetics and Pharmacodynamics of Higenamine in Chinese Healthy Subjects
A Phase 1 study testing higenamine in people with Healthy, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects Read more about this study
- Who is it for?
- Ages 19 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- higenamine
- Type of treatment
- Injection or infusion
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Jun 2009to Aug 2009
- 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 19 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subjects must meet all the following inclusion criteria to be eligible to participate in this study:
- Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3).
- Age: 19 to 45 (including 19, 45) years old.
- Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25).
- Informed consent form is obtained.
Who cannot join
- Subjects will be excluded from entry if any of the criteria listed below are met:
- Presence or history of any disorder of cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, allergy / immune system, blood system, nervous / mental system, musculoskeletal system, skin diseases.
- History of any drug hypersensitivity.
- Female urine pregnancy test was positive.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis C virus (HCV) antibodies.
- Acute disease state or infection associated with prescription drugs within 1 month before study day 1.
Show all 16Show fewer
- Taking any drugs, including over-the-counter drugs and herbal supplements within 7 days before study day 1.
- History of alcohol abuse (consuming greater than 14 glasses of alcoholic beverages each week, 1 glass is approximately equivalent to: beer 284 mL, wine 125 mL, or distilled spirits [25 mL).
- History of drug abuse.
- Smoker or subjects quitting smoking less than 1 month before study day 1.
- Participating other trials within 1 month before study day 1.
- Donating blood (> 400 mL) within 1 month before study day 1.
- During screening, alcohol breath test result > 0.000.
- Systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg.
- Heart rate was lower than 45 beats per minute (bpm) and/or higher than 90 bpm during rest.
- The investigator thought the subjects might not be able to complete the study or comply with the requirements of the study (due to management reasons or other reasons).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, Single-dose Administration Study of the Pharmacokinetics and Pharmacodynamics of Higenamine, Administered Intravenously Injection to Healthy Chinese Subjects
The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects
- Conditions
- Healthy
- Being tested
- higenamine
- Keywords
- pharmacokinetics, pharmacodynamics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
higenamineDrug
infused intravenously with higenamine at the escalating doses from 0.5 ug/kg/min through 1.0 ug/kg/min and 2.0 ug/kg/min to 4.0 ug/kg/min, each dose being given for 3 minutes
What is being measured
The primary outcome is the main question the study is designed to answer.
The maximum observed plasma concentration
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
area under the concentration-time curve
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
clearance
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
volume of distribution
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
terminal half-life
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
amount excreted in urine
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
renal clearance
Measured: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
heart rate
Measured: predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2011 (estimated)
- Study startJun 2009
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Jiang, 88068357, Principal investigator, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451229
- Sponsor's protocol ID
- 2009-PK003
- Status last verified
- Oct 2011
- First submitted
- 11 Oct 2011
- Last updated
- 13 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-dose Administration Study of the Pharmacokinetics and Pharmacodynamics of Higenamine, Administered Intravenously Injection to Healthy Chinese Subjects
- ClinicalTrials.gov ID
- NCT01451229
- Acronym / sponsor ID
- 2009-PK003
- Conditions
- Healthy
- Keywords
- pharmacokinetics, pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 13 Oct 2011 (estimated)
- 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 purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 19 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Subjects must meet all the following inclusion criteria to be eligible to participate in this study:
- Chinese healthy adult males, female subjects (either gender the proportion of not less than 1 / 3).
- Age: 19 to 45 (including 19, 45) years old.
- Male body weight ≥ 50kg, female body weight ≥ 45kg, and body mass index within the normal range (weight (kg) / height 2 (m2) = 18-25).
- Informed consent form is obtained.
Key exclusion criteria (16 listed)
- Presence or history of any disorder of cardiovascular system, respiratory system, digestive system, urogenital system, endocrine system, allergy / immune system, blood system, nervous / mental system, musculoskeletal system, skin diseases.
- History of any drug hypersensitivity.
- Female urine pregnancy test was positive.
- Positive serologic findings for human immunodeficiency virus (HIV) antibodies, hepatitis B surface antigen (HBsAg), hepatitis B e antigen (HBeAg), and/or hepatitis C virus (HCV) antibodies.
- Acute disease state or infection associated with prescription drugs within 1 month before study day 1.
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 |
|---|---|---|
| higenamineinfused intravenously with higenamine at the escalating doses from 0.5 ug/kg/min through 1.0 ug/kg/min and 2.0 ug/kg/min to 4.0 ug/kg/min, each dose being given for 3 minutes | Drug | – |
Primary outcome
The maximum observed plasma concentration
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
area under the concentration-time curve
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
clearance
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
volume of distribution
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
terminal half-life
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
amount excreted in urine
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
renal clearance
Time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose
heart rate
Time frame: predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2011.
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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.
Ji Jiang, 88068357 principal investigator
Chinese Academy of Medical Sciences
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 higenamine in people with Healthy, run by Peking Union Medical College Hospital 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 5 inclusion and 16 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: finished, as of the sponsor's last update on 13 Oct 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The maximum observed plasma concentration (time frame: predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose). The study lists 8 primary outcomes in all. 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 13 Oct 2011.