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Completed

NCT Number: NCT06211179

A Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to Intact Oral 5 mg Mavacamten in Healthy Participants

The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.

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Key information

Conditions

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Local Institution - 0001

San Antonio, Texas, 78217, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Participants must have a body mass index between 18 and 32 kg/m2.
  • Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments.
  • Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.

Exclusion criteria

  • Participants must not have any significant acute or chronic medical illness.
  • Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
  • Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic.

Other protocol-defined inclusion/exclusion criteria apply

Treatment and study plan

Treatment A: Mavacamten intact oral capsule

Drug

Specified dose on specified days

Treatment B: Mavacamten open capsule in suspension

Drug

Specified dose on specified days

Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)

Drug

Specified dose on specified days

Primary outcomes

  1. Maximum observed concentration (Cmax)

    Time frame: Up to 37 days

  2. Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])

    Time frame: Up to 37 days

  3. Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])

    Time frame: Up to 37 days

  4. Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])

    Time frame: Up to 37 days

Secondary outcomes

  1. Time of maximum observed plasma concentration (Tmax)

    Time frame: Up to 37 days

  2. Terminal half-life (T-HALF)

    Time frame: Up to 37 days

  3. Apparent clearance (CLT/F)

    Time frame: Up to 37 days

  4. Apparent volume of distribution (Vz/F)

    Time frame: Up to 37 days

  5. Number of participants with adverse events (AEs)

    Time frame: Up to 37 days

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

    Time frame: Up to 37 days

  7. Number of participants with vital sign abnormalities

    Time frame: Up to 37 days

  8. Number of participants with electrocardiogram (ECG) findings

    Time frame: Up to 37 days

  9. Number of participants with physical examination findings

    Time frame: Up to 37 days

  10. Number of participants with abnormalities in clinical laboratory evaluations

    Time frame: Up to 37 days

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

An Open-label, Randomized, Single-dose, Three-way Crossover Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to 5 mg Mavacamten Intact Capsule in Healthy Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 18, 2024
Registry last updated
Sep 19, 2024

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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