BIIB014 Cardiovascular Monitoring Study

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Placebo; Drug: BIIB014 50mg; Drug: BIIB014 100mg

• Registration Number: NCT01035515
• Lead Sponsor: Biogen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Study First Submitted: 2009-12-17
• Study First Submitted QC: 2009-12-17
• Study First Posted: 2009-12-18
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-17
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm Three	BIIB014 50mg	Arm 3 of 6 cross-over arms
Arm Three	BIIB014 100mg	Arm 3 of 6 cross-over arms
Arm Four	Placebo	Arm 4 of 6 cross-over arms
Arm Four	BIIB014 50mg	Arm 4 of 6 cross-over arms
Arm Four	BIIB014 100mg	Arm 4 of 6 cross-over arms
Arm Five	Placebo	Arm 5 of 6 cross-over arms
Arm Five	BIIB014 50mg	Arm 5 of 6 cross-over arms
Arm Five	BIIB014 100mg	Arm 5 of 6 cross-over arms
Arm Six	Placebo	Arm 1 of 6 cross-over arms
Arm Six	BIIB014 50mg	Arm 1 of 6 cross-over arms
Arm Six	BIIB014 100mg	Arm 1 of 6 cross-over arms
Arm One	BIIB014 100mg	Arm 1 of 6 cross-over arms
Arm Two	Placebo	Arm 2 of 6 cross-over arms
Arm Two	BIIB014 50mg	Arm 2 of 6 cross-over arms
Arm Two	BIIB014 100mg	Arm 2 of 6 cross-over arms
Arm Three	Placebo	Arm 3 of 6 cross-over arms
Arm One	Placebo	Arm 1 of 6 cross-over arms
Arm One	BIIB014 50mg	Arm 1 of 6 cross-over arms

Primary Outcome Measures

Name	Time	Method
Supine Blood pressure	24 hours

Trial Locations

Locations (1)

Quintiles Inc; 🇺🇸 Overland Park, Kansas, United States