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

NCT03611101 · Status: COMPLETED · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2022-12-20

Study results available
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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.

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-04
Primary Completion
2020-08-18
Completion
2021-11-10

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03611101 on ClinicalTrials.gov