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Trial ID CV027-1070  |   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

Summary

  • Phase 1
  • Male and Female Gender icon
  • 18-60
    Age Range
  • 1
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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 Eligibility Criteria

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 Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Experimental: Sequence ABC

ASSIGNED INTERVENTION
  • Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment A: Mavacamten intact oral capsule, Treatment B: Mavacamten open capsule in suspension

Study Arms

Experimental: Sequence BCA

ASSIGNED INTERVENTION
  • Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment B: Mavacamten open capsule in suspension, Treatment A: Mavacamten intact oral capsule

Study Arms

Experimental: Sequence CAB

ASSIGNED INTERVENTION
  • Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment B: Mavacamten open capsule in suspension, Treatment A: Mavacamten intact oral capsule
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