UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020971 |
|---|---|
| Receipt number | R000023921 |
| Scientific Title | Clinical pharmacology study of repeated intramuscular injections of G-CSF |
| Date of disclosure of the study information | 2016/02/12 |
| Last modified on | 2017/06/02 16:53:12 |
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Basic information
Public title
Clinical pharmacology study of repeated intramuscular injections of G-CSF
Acronym
Clinical pharmacology study of repeated intramuscular injections of G-CSF
Scientific Title
Clinical pharmacology study of repeated intramuscular injections of G-CSF
Scientific Title:Acronym
Clinical pharmacology study of repeated intramuscular injections of G-CSF
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the tolerability, safety and pharmacokinetics of repeated intramuscular injections of G-CSF in Japanese healthy adult subjects
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate the linearity and cumulative effects of repeated intramuscular G-CSF injections based on the PK parameters
Primary PK parameters: Cmax and AUC0-24 (Day1 and Day3)
Safety: Adverse events and adverse drug reactions (symptoms, objective findings, clinical examinations (hematology, biochemistry), vital signs, electrocardiogram)
Key secondary outcomes
Secondary PK parameters: AUC 0 to Infinity, tmax(Day1 and Day3), MRT(Day1), kel(Day1 and Day3) and t1/2(Day1 and Day3)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
G-CSF 1.0microG/kg/day
Interventions/Control_2
G-CSF 2.0microG/kg/day
Interventions/Control_3
G-CSF 5.0microG/kg/day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Those who are physically and mentally sound.
2) 20-39 years of age at the time of consent.
3) Those who can be hospitalized from Day -1 of the study.
4) Those who have agreed on the written informed consent.
5) Those who are capable to comply with all study procedures and restrictions.
6) Body weight; 50-80 kg and Body mass index (BMI); 18.5-25.0 kg/m2 at the screening examination.
7) Systolic blood pressure ; 90 mmHg to 140 mmHg and diastolic blood pressure; <90mmHg (sitting position) at the screening examination.
8) WBC 3,300-8,000/microL before the injection of the agent.
Key exclusion criteria
1) Those who are potentially pregnant.
2) Those who have a history of serious illnesses, or are under treatment for such illnesses.
3) Those who have a history of drug allergies.
4) Those who have a history of allergy to recombinant G-CSF agents.
5) Those who have a history of excessive alcohol abuse.
6) Smokers of cigarettes.
7) Those who had participated in an investigational drug study within the past 4 months.
8) Those who had used medicine within the past week.
9) Those who had a blood donation as follows; >200ml within the past 1 week, >400ml within the past 12 weeks, or >800ml within the past year.
10) Those who are positive for hepatitis B, hepatitis C, syphilis or HIV.
11) Those who are determined by the principle investigator inadequate as participants for the study.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichi Furihata |
Organization
P-One Clinic Keikokai Medical Corporation
Division name
Not applicable
Zip code
Address
View Tower Hachioji 4F, 8-1 Yokamachi Hachioji City, Tokyo 192-0071
TEL
042-625-5216
furihata@p1-clinic.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keio University Hospital Clinical and Translational Research Center |
Organization
Keio University Hospital
Division name
Clinical and Translational Research Center
Zip code
Address
#111, Clinical Research Building 35 Shinanomachi Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-5315-4278
Homepage URL
ccrkeio-project@umin.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医療法人社団慶幸会 ピーワンクリニック(東京都) P-One clinic, Keikokai Medical Corporation
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
| 2016 | Year | 04 | Month | 14 | Day |
Date analysis concluded
| 2016 | Year | 04 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 02 | Month | 10 | Day |
Last modified on
| 2017 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023921
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
