A Study in Healthy Volunteers to Evaluate Effects of Pre-Medication or Slow Dose Titration on Flushing and Gastrointestinal Events

Healthy Clinical Trial

Official title:

A Randomized, Double-Blind, Phase 3b Study to Evaluate Effects of Aspirin or Slow Dose Titration on Flushing and Gastrointestinal Events Following Oral Administration of BG00012 Dosed at 240 mg BID

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568112
• Other study ID #: 109HV321
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2012
• Last updated: November 3, 2014
• Start date: April 2012
• Est. completion date: October 2012

Study information

• Verified date: November 2014
• Source: Biogen
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate whether premedication with 325 mg microcoated aspirin (ASA) tablet or a slow-titration dosing schedule of BG00012 reduces the incidence and severity of flushing and GI events following oral administration of BG00012 dosed at 240 mg twice a day (BID) in healthy volunteers. The secondary objective of this study is to evaluate the safety and tolerability of BG00012 when administered orally as a 240 mg BID dose regimen with and without 325 mg ASA premedication or following a slow-titration dosing schedule in healthy volunteers.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: October 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 55 Years

Eligibility

Key Inclusion Criteria:

• Must give written informed consent and any authorizations required by local law

• Must have a body mass index (BMI) of between 18.0 to 34.0 kg/m2,inclusive.

• Ability to complete the tolerability scales by accurately using the hand-held subject reporting device

• Subjects of childbearing potential must be willing to practice effective contraception

Key Exclusion Criteria:

• History of clinically significant diseases

• History of severe allergic or anaphylactic reactions

• Intolerance to Aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs)

• Diarrhea, constipation, abdominal pain, flushing or nausea within 28 days prior to Day 1

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Flushing
• Healthy

Intervention

Drug:
• BG00012 (dimethyl fumarate)
Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks.
• BG00012 placebo
Placebo matching BG00012
• ASA
325 mg microcoated aspirin (ASA)
• ASA placebo
Placebo matching aspirin

Locations

Country	Name	City	State
United States	Research Site	St Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Biogen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence and severity of flushing based on the Modified Flushing Severity Scale (MFSS)		Day 1 to Week 8	Yes
Primary	Incidence and severity of flushing based on the Modified Global Flushing Severity Scale (MGFSS)		Day 1 to Week 8	Yes
Primary	The incidence and severity of gastrointestinal events by using modified acute gastrointestinal scale (MAGISS)		Day 1 to Week 8	Yes
Primary	The incidence and severity of gastrointestinal events by using modified overall gastrointestinal scale (MOGISS)		Day 1 to Week 8	Yes
Secondary	Number of Participants with Adverse Events as a measure of safety and tolerability		Day 1 up to week 9	Yes
Secondary	Duration of Flushing side effects based on modified acute flushing scale and the modified global flushing scale		Day 1 to Week 8	Yes
Secondary	Duration of GI side effects based on modified acute gastrointestinal scale and modified overall gastrointestinal symptom scale		Day 1 to Week 8	Yes