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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000018828
Receipt No. 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

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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
Email 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
Email nakatani@cardiology.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021618

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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