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Completed

NCT Number: NCT05320094

A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose 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.

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Key information

Conditions

Healthy Participants Anthrax Bacillaceae Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

Dallas, Texas, 75247-4989, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mavacamten

Drug

Specified dose on specified days

Activated Charcoal with Sorbitol

Drug

Specified dose on specified days

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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Apr 11, 2022
Registry last updated
Nov 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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