Evaluation of CYP2C9 Activity | NCT00162461

Studies
Evaluation of CYP2C9 Activity

NCT00162461

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Jun 12, 2018Actual

Enrollment

1,200Estimated

Phase

Not Applicable

Conditions

Healthy

Interventions

Phenytoin single dose (300 mg)

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1998

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Sep 11, 2005

First Submission Date that Met QC Criteria

Sep 11, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2018

Last Update Posted Date

Jun 12, 2018Actual

Name	Class
United States - Israel Binational Science Foundation	OTHER

Description Module

Brief Summary

The use of phenytoin metabolism to produce S-HPPH accounts for more than 85% of its metabolism. This metabolic pathway is mediated by the activity of CYP2C9.

The purpose of the present study is:

To confirm the use of phenytoin metabolic ratio as a marker of CYP2C9 activity
To correlate phenytoin metabolic ratio with CYP2C9 genotype
To study the frequency distribution of CYP2C9 activity in-vivo

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,200Estimated

Label	Type	Description	Intervention Names
Phenytoin	Experimental		Drug: Phenytoin single dose (300 mg)

Name	Type	Description	Arm Group Labels	Other Names
Phenytoin single dose (300 mg)	Drug		Phenytoin

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between phenytoin metabolic ratio and CYP2C9 genotype		24 hours
Frequency distribution of phenytoin metabolic ratio in the population		24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age range of 20-50 years old
Absence of significant disease states

Exclusion Criteria:

The presence of significant disease states
The use of drugs (including birth control pills)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yoseph Caraco, MD	Contact	00 972 2 6778584		caraco@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Yoseph Caraco, MD	Hadassah Medical Organization	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hadassah Medical Organization	Recruiting	Jerusalem			Israel

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010672	Phenytoin

Ancestor Terms

ID	Term
D006827	Hydantoins
D048289	Imidazolidines
D007093	Imidazoles
D001393	Azoles
D006573

Browse Leaves

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Browse Branches

Not provided