Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials

CompletedINTERVENTIONAL
Enrollment

124

Participants

Timeline

Start Date

May 4, 2018

Primary Completion Date

August 18, 2020

Study Completion Date

November 10, 2021

Conditions
NASH - Nonalcoholic Steatohepatitis
Interventions
COMBINATION_PRODUCT

¹³C-Methacetin Breath Test

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.

DRUG

BMS-986036

Investigational drug for NASH treatment in Main BMS protocol

DEVICE

BreathID MCS device

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.

Trial Locations (1)

77338-4125

Spring Gastroenterology, Humble

Sponsors
All Listed Sponsors
collaborator

Bristol-Myers Squibb

INDUSTRY

lead

Meridian Bioscience, Inc.

INDUSTRY