NCT01035515

Brief Summary

The study will examine the effects of a single dose of BIIB014 on blood pressure and haemodynamic variables in healthy volunteers over 24 hours.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at P25-P50 for phase_1 healthy

Timeline
Completed

Started Dec 2009

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

December 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 22, 2010

Status Verified

June 1, 2010

Enrollment Period

4 months

First QC Date

December 17, 2009

Last Update Submit

June 17, 2010

Conditions

Healthy

Keywords

Healthy subjects

Outcome Measures

Primary Outcomes (1)

  • Supine Blood pressure

    24 hours

Study Arms (6)

Arm One

EXPERIMENTAL

Arm 1 of 6 cross-over arms

Drug: PlaceboDrug: BIIB014 50mgDrug: BIIB014 100mg

Arm Two

EXPERIMENTAL

Arm 2 of 6 cross-over arms

Drug: PlaceboDrug: BIIB014 50mgDrug: BIIB014 100mg

Arm Three

EXPERIMENTAL

Arm 3 of 6 cross-over arms

Drug: PlaceboDrug: BIIB014 50mgDrug: BIIB014 100mg

Arm Four

EXPERIMENTAL

Arm 4 of 6 cross-over arms

Drug: PlaceboDrug: BIIB014 50mgDrug: BIIB014 100mg

Arm Five

EXPERIMENTAL

Arm 5 of 6 cross-over arms

Drug: PlaceboDrug: BIIB014 50mgDrug: BIIB014 100mg

Arm Six

EXPERIMENTAL

Arm 1 of 6 cross-over arms

Drug: PlaceboDrug: BIIB014 50mgDrug: BIIB014 100mg

Interventions

PlaceboDRUG

Single dose oral capsule placebo comparator

Arm FiveArm FourArm OneArm SixArm ThreeArm Two
BIIB014 50mgDRUG

Single dose oral capsule 50mg BIIB014

Arm FiveArm FourArm OneArm SixArm ThreeArm Two
BIIB014 100mgDRUG

Single dose oral capsule 100mg BIIB014

Arm FiveArm FourArm OneArm SixArm ThreeArm Two

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female subjects
  • Between the ages of 18 and 50, 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)

Quintiles Inc

Overland Park, Kansas, 66211, United States

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
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 17, 2009

First Posted

December 18, 2009

Study Start

December 1, 2009

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 22, 2010

Record last verified: 2010-06

Locations

US(1)