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 |
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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
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
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
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
