BIIB014 Cardiovascular Monitoring Study

A Single-Center, Randomized, Placebo-Controlled, Double-Blind, Crossover Study to Evaluate the Cardiovascular Effects of Single Doses of Oral BIIB014 in Healthy Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01035515

Enrollment

Registered

2009-12-18

Start date

2009-12-31

Completion date

2010-04-30

Last updated

2010-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

Healthy subjects

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.

Interventions

DRUGBIIB014 50mg

Single dose oral capsule 50mg BIIB014

DRUGPlacebo

Single dose oral capsule placebo comparator

DRUGBIIB014 100mg

Single dose oral capsule 100mg BIIB014

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 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

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)

Design outcomes

Primary

Measure	Time frame
Supine Blood pressure	24 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026