NCT01451229

Brief Summary

The purpose of this study is to assess the pharmacokinetics and pharmacodynamics of higenamine in healthy Chinese subjects

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 11, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 13, 2011

Completed
Last Updated

October 13, 2011

Status Verified

October 1, 2011

Enrollment Period

2 months

First QC Date

October 11, 2011

Last Update Submit

October 12, 2011

Conditions

Healthy

Keywords

pharmacokineticspharmacodynamics

Outcome Measures

Primary Outcomes (8)

  • The maximum observed plasma concentration

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • area under the concentration-time curve

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • clearance

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • volume of distribution

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • terminal half-life

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • amount excreted in urine

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • renal clearance

    predose and at 1, 3, 5, 7, 9, 12, 15, 20, 30, 60 and 90 minutes postdose

  • heart rate

    predose and at 2, 5, 8, 11, 13, 15, 17, 27 and 42 minutes postdose

Interventions

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

Eligibility Criteria

Age19 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College

Beijing, China

Location

MeSH Terms

Interventions

higenamine

Study Officials

  • Ji Jiang, 88068357

    Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2011

First Posted

October 13, 2011

Study Start

June 1, 2009

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 13, 2011

Record last verified: 2011-10

Locations

CN(1)