PeptoBismol® Use to Reduce Gastrointestinal Events in Healthy Volunteers Receiving DMF [Tecfidera®] Twice Daily

NCT01915901 | Completed Phase 1

• 1 other identifier: 109HV110
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 3

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Time to first gastrointestinal-related event

  Up to 8 weeks

Secondary Outcomes (4)

• The number of gastrointestinal-related events.

  Up to 8 weeks

• The duration of gastrointestinal-related events.

  Up to 8 weeks

• The severity of gastrointestinal-related events.

  Up to 8 weeks

• The percentage of subjects who discontinue dimethyl fumarate (DMF) due to gastrointestinal-related events

  Up to 8 weeks

Study Arms (2)

bismuth subsalicylate (Pepto-Bismol®) + DMF

EXPERIMENTAL

Subjects will receive dimethyl fumarate (DMF) and bismuth subsalicylate (Pepto-Bismol®).

Drug: bismuth subsalicylate (Pepto-Bismol®); Drug: dimethyl fumarate (DMF)

Placebo + DMF

EXPERIMENTAL

Subjects will receive dimethyl fumarate (DMF) and placebo.

Drug: matching placebo (bismuth subsalicylate); Drug: dimethyl fumarate (DMF)

Interventions

bismuth subsalicylate (Pepto-Bismol®) DRUG

524 mg bismuth subsalicylate twice a day (BID)

Also known as: Pepto-Bismol®

bismuth subsalicylate (Pepto-Bismol®) + DMF

matching placebo (bismuth subsalicylate) DRUG

placebo twice a day (BID)

Placebo + DMF

dimethyl fumarate (DMF) DRUG

dimethyl fumarate (DMF) twice a day (BID)

Also known as: BG00012, DMF, TECFIDERA™

Placebo + DMF; bismuth subsalicylate (Pepto-Bismol®) + DMF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Biogen: lead

Study Sites (3)

Research Site

Daytona Beach, Florida, 32117, United States

Location

Research Site

Dallas, Texas, 75247, United States

Location

Research Site

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• 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.

  PMID: 30447891 DERIVED

MeSH Terms

Interventions

bismuth subsalicylate; Dimethyl Fumarate

Intervention Hierarchy (Ancestors)

Fumarates; Dicarboxylic Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• Medical Director

  Biogen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2013
• First Posted: August 5, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 3, 2014

Record last verified: 2014-02

Locations

US (3)