Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials
Condition: NASH - Nonalcoholic Steatohepatitis
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional

Summary: 
      This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects
      participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced
      studies using study drug BMS-986036.
    

Detailed description: 
      Subjects that are enrolled into either of two separate BMS sponsored IND (Investigational New
      Drug) studies (referenced by NCT03486899 and NCT03486912) at selected study sites will be
      offered the opportunity to perform the MBT. These will be considered as two separate study
      cohorts (cohort 1 and 2 respectively) within this companion protocol. There are four (4)
      treatment arms (BMS-986036 Dose Level 1, Dose Level 2, Dose Level 3 or matching placebo), as
      defined in the respective BMS sponsored protocols.

      Cohort 1 consists of Subjects with NASH and stage 3 fibrosis, as assessed by a central
      laboratory reader of the liver biopsies (up to 160), and who meet all the NCT03486899
      referenced study criteria.

      Cohort 2 consists of Subjects with NASH and compensated liver cirrhosis, as assessed by a
      central laboratory reader of the liver biopsies (up to100), and who meet all the NCT03486912
      referenced study criteria.

      Approximately 75 sites will be included in the BMS studies, but not all participating sites
      will elect to perform the MBT. Each subject will perform up to 3 MBTs over 1 year;
      approximately one every 24 weeks.

      The MBT in this study will only be conducted in the USA.

      The primary purpose of the BMS study is to assess an experimental treatment for the following
      conditions: Hepatic cirrhosis, liver fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD) and
      NASH (Nonalcoholic Steatohepatitis).
    

Intervention name(s): ¹³C-Methacetin Breath Test; BMS-986036; BreathID MCS device
Intervention type(s): Combination Product; Drug; Device
Intervention description(s): A breath analyzer will be used to measure changes in 12C (carbon 12) to 13C (carbon 13) ratio as a result of metabolism of the Methacetin substrate before and after treatment.; Investigational drug for NASH treatment in Main BMS protocol; The BreathID MCS device is a breath analyzer specifically used for measuring changes in the ratio of 13CO2 and 12CO2 isotopes of carbon dioxide. The device is connected to the subject via a nasal cannula and breath is passively collected before and after ingestion of labelled 13C- Methacetin substrate.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will be enrolled and randomized via interactive response technology (IRT) to receive BMS-9860936 Dose Level 1 , BMS-986036 Dose Level 2, BMS-9860936 Dose Level 3 or matching placebo in a 1:1:1:1 ratio. in both Stage 3 liver fibrosis and cirrhosis cohorts.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic