A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants

November 4, 2022 updated by: Bristol-Myers Squibb

An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants

The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75247-4989
        • Local Institution - 0001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index between 18 and 30 kg/m^2, inclusive, at the Screening Visit
  • Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments

Exclusion Criteria:

  • Current or recent (within 3 months of study intervention administration) gastrointestinal disease
  • History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
  • History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)

Other protocol-defined inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Mavacamten
Drug: Mavacamten
Specified dose on specified days
EXPERIMENTAL: Mavacamten and activated charcoal with sorbitol - Dose A
Drug: Mavacamten
Specified dose on specified days
Drug: Activated Charcoal with Sorbitol
Specified dose on specified days
EXPERIMENTAL: Mavacamten and activated charcoal with sorbitol - Dose B
Drug: Mavacamten
Specified dose on specified days
Drug: Activated Charcoal with Sorbitol
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
Time Frame: Up to 2 months
Up to 2 months
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))
Time Frame: Up to 2 months
Up to 2 months
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 1 month
Up to 1 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of participants with adverse events (AEs)
Time Frame: Up to 3 months
Up to 3 months
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 3 months
Up to 3 months
Number of participants with vital sign abnormalities exceeding predefined thresholds
Time Frame: Up to 3 months
Up to 3 months
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 3 Months
Up to 3 Months
Number of participants with physical exam abnormalities
Time Frame: Up to 3 months
Up to 3 months
Number of participants with clinical laboratory evaluation abnormalities
Time Frame: Up to 3 months
Up to 3 months
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 1 month
Up to 1 month
Apparent terminal plasma half-life (T-HALF)
Time Frame: Up to 2 months
Up to 2 months
Concentration at 24 hours (C24)
Time Frame: Up to 1 month
Up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2022

Primary Completion (ACTUAL)

September 11, 2022

Study Completion (ACTUAL)

September 11, 2022

Study Registration Dates

First Submitted

April 1, 2022

First Submitted That Met QC Criteria

April 1, 2022

First Posted (ACTUAL)

April 11, 2022

Study Record Updates

Last Update Posted (ACTUAL)

November 8, 2022

Last Update Submitted That Met QC Criteria

November 4, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV027-043

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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