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

Biogen

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: BIIB014

Study type: Interventional

Funder types: Industry

Identifiers

NCT01017666

EUDRA CT 2009-014259-60

204HV103

Details and patient eligibility

About

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

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

28 participants in 2 patient groups

Rosiglitazone 8mg PO

Experimental group

Description:

Cohort 1

Treatment:

Drug: BIIB014

Drug: Placebo

Midazolam 2mg PO, Warfarin 25mg PO

Experimental group

Description:

Cohort 2

Treatment:

Drug: BIIB014

Drug: Placebo