BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglita... | NCT01017666

Studies
BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam

NCT01017666

Sponsor

Biogen

Status

Completed

Last Update Posted

Aug 23, 2023Actual

Enrollment

28Actual

Phase

Phase 1

Conditions

Healthy

Interventions

BIIB014
Placebo

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

ID	Type	Description	Link
EUDRA CT 2009-014259-60

Status Module

Record Verification Date

Aug 2023

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

Nov 1, 2009Actual

Primary Completion Date

Jun 2, 2010Actual

Completion Date

Jun 2, 2010Actual

First Submitted Date

Nov 16, 2009

First Submission Date that Met QC Criteria

Nov 19, 2009

First Posted Date

Nov 20, 2009Estimated

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

Aug 21, 2023

Last Update Posted Date

Aug 23, 2023Actual

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

The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.

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

28Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Rosiglitazone 8mg PO	Experimental	Cohort 1	Drug: BIIB014 Drug: Placebo
Midazolam 2mg PO, Warfarin 25mg PO	Experimental	Cohort 2	Drug: BIIB014 Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BIIB014	Drug	BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d	Midazolam 2mg PO, Warfarin 25mg PO Rosiglitazone 8mg PO

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo		24 hours (Cohort 1); 144 hours (Cohort 2)

Secondary Outcomes

Measure	Description	Time Frame
Adverse Events		Duration of subject participation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female subjects
Between the ages of 18 and 45, inclusive.
Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive

Exclusion Criteria:

Clinically significant abnormalities (as determined by the Investigator)
Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
InCROM Clinical Research Unit		London		E14NL	United Kingdom

Intervention Browse Module

MeSH Terms

ID	Term
C547274	3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided