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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 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


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

Value
https://center6.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