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UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004621
Receipt No. 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

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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
Institute Clinical trial Center,Kitasato University East Hospital
Institute
Department

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
URL(English) https://upload.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


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