NCT01017666

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Nov 2009

Typical duration for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 2, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 2, 2010

Completed
Last Updated

August 23, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

November 16, 2009

Last Update Submit

August 21, 2023

Conditions

Healthy

Keywords

Healthy Volunteer

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Adverse Events

    Duration of subject participation

Study Arms (2)

Rosiglitazone 8mg PO

EXPERIMENTAL

Cohort 1

Drug: BIIB014Drug: Placebo

Midazolam 2mg PO, Warfarin 25mg PO

EXPERIMENTAL

Cohort 2

Drug: BIIB014Drug: Placebo

Interventions

BIIB014DRUG

BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d

Midazolam 2mg PO, Warfarin 25mg PORosiglitazone 8mg PO
PlaceboDRUG

Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d

Midazolam 2mg PO, Warfarin 25mg PORosiglitazone 8mg PO

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

InCROM Clinical Research Unit

London, E14NL, United Kingdom

Location

MeSH Terms

Interventions

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

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2009

First Posted

November 20, 2009

Study Start

November 1, 2009

Primary Completion

June 2, 2010

Study Completion

June 2, 2010

Last Updated

August 23, 2023

Record last verified: 2023-08

Locations

GB(1)