Study to Evaluate the Potential for Interaction Between O... | NCT01056575

Studies
Study to Evaluate the Potential for Interaction Between OC000459 and CYP 450 3A4

NCT01056575

Sponsor

Oxagen Ltd

Status

Completed

Last Update Posted

Sep 2, 2010Estimated

Enrollment

20Estimated

Phase

Phase 1

Conditions

Healthy Volunteers

Interventions

OC000459

Countries

United Kingdom

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

Sep 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2010

Primary Completion Date

Apr 2010Actual

Completion Date

May 2010Actual

First Submitted Date

Jan 25, 2010

First Submission Date that Met QC Criteria

Jan 25, 2010

First Posted Date

Jan 26, 2010Estimated

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

Sep 1, 2010

Last Update Posted Date

Sep 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This will be an open label, sequential study of midazolam (dose 5 mg orally) followed by midazolam (5 mg orally) given after dosing with OC000459 100 mg twice daily for 6.5 days. Twenty subjects will be included to ensure at least 16 subjects with analysable PK data. PK sampling for midazolam and 4-hydroxymidazolam plasma concentrations will continue for up to and including 24 hours after dosing with midazolam on both occasions.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OC000459	Experimental		Drug: OC000459

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OC000459	Drug	OC000459 100mg tablet, twice daily	OC000459

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ratio of exposure of midazolam and 4-hydroxymidazolam (without/with exposure to OC000459) as measured by plasma AUC0-t and Cmax for midazolam and its active metabolite 4-hydroxymidazolam.		6.5 days

Secondary Outcomes

Measure	Description	Time Frame
Additional PK parameters of midazolam and its active metabolite 4-hydroxymidazolam		6.5 days
Safety and tolerability of OC000459		6.5 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Judged to be in good health at screening (blood tests, physical examination, medical history)

Exclusion Criteria:

Evidence of a clinically significant underlying medical condition that in the opinion of the Investigator would represent a risk to study participation.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Salvatore Febbraro, Dr	Simbec Research	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Simbec Research Ltd		Merthyr Tydfil		CF48 4DR	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C571151	(5-fluoro-2-methyl-3-quinolin-2-ylmethylindo-1-yl)acetic acid

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided