UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000004621
Receipt number R000005438
Scientific Title Effect of a pharmaceutical excipient, cremophol EL on the plasma concentration-time profile of saquinavir and fexofenadine after their oral administrations at doses used in the exploratory investigational new drug clinical studies
Date of disclosure of the study information 2010/11/25
Last modified on 2012/07/13 14:18:04

* 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

Effect of a pharmaceutical excipient, cremophol EL on the plasma concentration-time profile of saquinavir and fexofenadine after their oral administrations at doses used in the exploratory investigational new drug clinical studies

Acronym

Effect of cremophol EL on pharmacokinetics of saquinavir and fexofenadine at doses used in the exploratory investigational new drug clinical studies

Scientific Title

Effect of a pharmaceutical excipient, cremophol EL on the plasma concentration-time profile of saquinavir and fexofenadine after their oral administrations at doses used in the exploratory investigational new drug clinical studies

Scientific Title:Acronym

Effect of cremophol EL on pharmacokinetics of saquinavir and fexofenadine at doses used in the exploratory investigational new drug clinical studies

Region

Japan


Condition

Condition

healthy male subjects

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine the effect of a pharmaceutical excipient, cremophol EL on the GI absorption of saquinavir mesilate (P-gp and CYP3A substrates) and fexofenadine hydrochloride (P-gp substrates) at doses used in the exploratory investigational new drug clinical studies (semi microdose for saquinavir mesilate and microdose for fexofenadine hydrochloride)

Basic objectives2

Others

Basic objectives -Others

nothing

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

pharamacokinetics of saquinavir and fexofenadine

Key secondary outcomes

safety


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

oral administration of saquinavir and fexofenadine->oral administration of saquinavir, fexofenadine and low dose of cremophor EL->oral administration of saquinavir, fexofenadine and high dose of cremophor EL

Interventions/Control_2


Interventions/Control_3


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

Key inclusion criteria

1)Ability to understand and willing to sign the informed consent.
2)Japanese healthy male subjects age 20 to 40 years of age
3)Body weight between 50 kg and 100 kg, and a body mass index(BMI)between 18.5 and 27 kg/m2.
4)Healthy subject as determined by medical history, physical examination, ECGs, and clinical laboratory tests.

Key exclusion criteria

1)Any hypersensitivities to saquinavir, fexofenadine or cremophor EL.
2)Any subject with impaired hepatic function.
3)Use of medicine as follow;amiodarone, flecainide, propafenone, bepridil, quinidine, pimozide, ergotamine preparation, simvastatin, midazolam, triazolam, rifampicin, vardenafil, terfenadine, astemizole, cisapride.
4)Use of medicine, health product including Saint John's wort or garlic supplyment 2 weeks before pre-dose.
5)Intake of fruit food and drink including grapefruit juice, orange juice or apple juice from 7 days before pre-dose.
6)Participation to any other clinical reseach in the past 3 months.
7)Donating over 200 ml of blood in the past 1 month or over 400ml of blood in the past 3 months.
8)Positive tests of serological reaction for syphilis, HIV antigen and antibody, HBs antigen or HCV antibody.
9)Any allergy to drug and food
10)Drug abuse or positive drug screening
11)Any condition that, in the opinion of the investigator, would make the patient unsuitable for the study.

Target sample size

8


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuji Kumagai

Organization

Kitasato University East Hospital

Division name

Clinical trial Center

Zip code


Address

2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Kitasato University East Hospital

Division name

Clinical trial Center

Zip code


Address

2-1-1 Asamizodai, Minami, Sagamihara, Kanagawa, 252-0380 Japan

TEL


Homepage URL


Email



Sponsor or person

Institute

Clinical trial Center,Kitasato University East Hospital

Institute

Department

Personal name



Funding Source

Organization

APDD, Association for Promoting Drug Development

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



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

2010 Year 11 Month 25 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

No longer recruiting

Date of protocol fixation

2010 Year 11 Month 10 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2010 Year 11 Month 25 Day

Last modified on

2012 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005438


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name