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CompletedNCT05320094Updated Nov 8, 2022

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

A Phase 1 interventional study of Mavacamten and Activated Charcoal with Sorbitol in Healthy Participants, sponsored by Bristol-Myers Squibb. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-08.

Sponsored by Bristol-Myers Squibb · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2022, 4 years ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
45
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy Participants

Keywords

  • Mavacamten
  • Sorbitol
  • Activated Charcoal
03

In context

Lead sponsor

Bristol-Myers Squibb is the lead sponsor of 1,538 studies on the registry; 116 are open to participants now.

Of its 429 completed or terminated interventional studies of FDA-regulated products, 223 (52%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
45 participants (actual)

Study arms

  • Experimental
    Mavacamten

    Drug: Mavacamten

  • Experimental
    Mavacamten and activated charcoal with sorbitol - Dose A

    Drug: Mavacamten · Drug: Activated Charcoal with Sorbitol

  • Experimental
    Mavacamten and activated charcoal with sorbitol - Dose B

    Drug: Mavacamten · Drug: Activated Charcoal with Sorbitol

Interventions

  • DrugMavacamten

    Specified dose on specified days

  • DrugActivated Charcoal with Sorbitol

    Specified dose on specified days

06

What researchers measure

Primary outcomes

  1. Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))

    Time frame: Up to 2 months

  2. 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

  3. Maximum observed plasma concentration (Cmax)

    Time frame: Up to 1 month

Secondary outcomes

  1. Number of participants with adverse events (AEs)

    Time frame: Up to 3 months

  2. Number of participants with serious adverse events (SAEs)

    Time frame: Up to 3 months

  3. Number of participants with vital sign abnormalities exceeding predefined thresholds

    Time frame: Up to 3 months

  4. Number of participants with electrocardiogram (ECG) abnormalities

    Time frame: Up to 3 Months

  5. Number of participants with physical exam abnormalities

    Time frame: Up to 3 months

  6. Number of participants with clinical laboratory evaluation abnormalities

    Time frame: Up to 3 months

  7. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 1 month

  8. Apparent terminal plasma half-life (T-HALF)

    Time frame: Up to 2 months

  9. Concentration at 24 hours (C24)

    Time frame: Up to 1 month

07

Study locations

1 site
  • Local Institution - 0001
    Dallas, Texas 75247-4989, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 8, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05320094
Lead sponsor
Bristol-Myers Squibb
Responsible party
Sponsor
First posted
Apr 11, 2022
Start date
Apr 15, 2022
Primary completion
Sep 11, 2022
Completion
Sep 11, 2022
Last update
Nov 8, 2022

Study contacts

Bristol-Myers Squibb
study director · Bristol-Myers Squibb

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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