UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018828 |
|---|---|
| Receipt number | R000021618 |
| Scientific Title | A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers |
| Date of disclosure of the study information | 2015/09/01 |
| Last modified on | 2015/09/07 10:28:31 |
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Basic information
Public title
A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers
Acronym
A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers
Scientific Title
A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers
Scientific Title:Acronym
A randomized single-blind phase 1 clinical trial of OSKLIPO-0524, a liposomal cyclosporine, to assess pharmacokinetics and safety in Japanese healthy volunteers
Region
| Japan |
Condition
Condition
Acute myocardial infarction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the pharmacokinetics and saftey of OSKLIPO-0524 in Japanese healthy volunteers
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
Pharmacokinetic parameters (Cmax, T1/2, AUC) of cyclosporine
Key secondary outcomes
Saftey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
OSKLIPO-0524 0.15 mg/kg, single administration
Interventions/Control_2
OSKLIPO-0524 0.5 mg/kg, single administration
Interventions/Control_3
OSKLIPO-0524 1.0 mg/kg, single administration
Interventions/Control_4
Placebo
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
| 45 | years-old | >= |
Gender
Male
Key inclusion criteria
1)Japanese healthy male age >=20 years and <= 40 years old at the time of informed consent
2)Japanese healthy male who passes screening tests and examination before administration of the drug
3)After receiving a sufficient explanation upon participation in this trial, on a full understanding, Japanese healthy male who obtained the written informed consent from each subject
Key exclusion criteria
1) A subject who has cardiovascular,kidney, liver, blood or autoimmune system diseases
2) BMI (kg/m2) <17.5 or >=30.0
3) A subject who has HCV Ab, HIV Ab, HBs Ag positive by screening test
4) A subject who has or is suspected to have the past of clinically significant drug allergy symptoms
5) A subject who has or is suspected to have the past of significant allergic diseases including bronchial asthma, urticaria or atopy, but not seasonal allergy
6) A subject with diseases and symptoms requiring systemic drugs
7) A subject who has or suspeted to have a past histroy of drug or alcohol dependency
8) A subject who received vaccine within four months
9) A subject who participated in other clinical trials within 4 months and received a clinical trial drug (including a placebo)
10) A subject taking prescribed drugs and/or Over-The-Counter drugs
11) Ineligible judged by the investigators
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tetsuo Minamino |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
+81-6-6879-3635
minamino@cardiology.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisaku Nakatani |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
Address
2-2 Yamadaoka, Suita, Osaka, Japan
TEL
+81-6-6210-8289
Homepage URL
nakatani@cardiology.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 07 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 27 | Day |
Last modified on
| 2015 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021618
