Clinical trial NCT01915901: PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily
Official title: A Multicenter, Double Blind, Placebo-Controlled Study of Pepto-Bismol® (Bismuth Subsalicylate) on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral TECFIDERA™ (Dimethyl Fumarate) Delayed-Release Capsules Twice Daily
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2013-08-05
Enrollment: 175
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary objective of the study is to determine the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on gastrointestinal (GI)-related events reported in healthy volunteers receiving TECFIDERA™ (dimethyl fumarate \[DMF\]; also known as BG00012) twice daily (BID) The secondary objectives of this study in this study population are: To characterize the effect of bismuth subsalicylate (Pepto-Bismol®) 524 mg versus placebo on the frequency, severity, and duration of GI-related events and to evaluate GI-related events that lead to discontinuation of DMF.


Eligibility criteria: Key Inclusion Criteria:

* Must be in good health as determined by the Principal Investigator (PI) based on medical history and Screening evaluations (clinical laboratory evaluations, 12-lead electrocardiogram (ECG), and vital signs; see below for specific exclusion criteria).
* Must have a body mass index (BMI) of 18.0 to 34.0 kg/m2, inclusive.
* Subjects of reproductive potential (including males) must practice effective contraception during the study and be willing and able to continue contraception for 90 days after their last dose of study drug.
* Male subjects must agree to not donate sperm for 90 days after their last dose of study drug.
* Must be naïve to dimethyl fumarate (DMF) or fumaric acid esters.

Key Exclusion Criteria:

* History of or positive results at the Screening visit for HIV.
* History of or positive results at the Screening visit for hepatitis C virus antibody or hepatitis B virus (defined as positive for hepatitis B surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\]).
* History of clinically significant gastrointestinal (GI) disease as determined by the PI (including Crohn's disease, peptic ulcer disease, ulcerative colitis, or confirmed diagnosis of irritable bowel syndrome) or active GI disease with ongoing symptoms.
* History of severe allergic or anaphylactic reactions, considered clinically relevant by the PI.
* Known allergy to Pepto-Bismol®, salicylates, or non-steroidal anti-inflammatory drugs, considered clinically relevant by the PI.
* Female subjects who are pregnant based on results of the serum pregnancy test at Screening or currently breastfeeding.
* Current enrollment in any other study treatment or disease study.
* Receipt of any investigational drug within 5 half-lives or 30 days, whichever is longer, prior to study entry.
* History of alcohol abuse or substance abuse (as determined by the PI) within the previous 5 years, a positive urine drug/alcohol test at Screening, or alcohol use prior to the screening visit.
* Regular use of any tobacco product, defined as smoke or smokeless product use equivalent to \>5 cigarettes/day for any consecutive week, within 3 months prior to Day 1.

Other unspecified reasons that, in the opinion of the PI or Biogen Idec, make the subject unsuitable for enrollment.

Other protocol-defined Inclusion/Exclusion criteria may apply

Primary outcomes:
measure: Time to first gastrointestinal-related event
timeFrame: Up to 8 weeks
Secondary outcomes:
measure: The number of gastrointestinal-related events.
timeFrame: Up to 8 weeks
measure: The duration of gastrointestinal-related events.
timeFrame: Up to 8 weeks
measure: The severity of gastrointestinal-related events.
timeFrame: Up to 8 weeks
measure: The percentage of subjects who discontinue dimethyl fumarate (DMF) due to gastrointestinal-related events
timeFrame: Up to 8 weeks
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Research Site
state: Florida
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Madison
country: United States
facility: Research Site
state: Wisconsin
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Koulinska I, Riester K, Chalkias S, Edwards MR. Effect of Bismuth Subsalicylate on Gastrointestinal Tolerability in Healthy Volunteers Receiving Oral Delayed-release Dimethyl Fumarate: PREVENT, a Randomized, Multicenter, Double-blind, Placebo-controlled Study. Clin Ther. 2018 Dec;40(12):2021-2030.e1. doi: 10.1016/j.clinthera.2018.10.013. Epub 2018 Nov 15.