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Recruiting

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 - CV027-1070

Updated: 29 February, 2024   |   ClinicalTrials.gov

Print Friendly Summary

CONSIDERING THIS TRIAL?
Print this page and the trial guide to help you talk with your doctor.
Use the Study Participant's Guide to navigate the process of participating in a clinical trial. Understand key factors to consider before deciding and get questions to ask your healthcare team.

Trial Details

  • Phase 1

    Phase

  • Gender(s)

  • 18-60

    Age Range

  • 1

    Location(s)

  • Recruiting

Treatment Options

Study Arms
ASSIGNED INTERVENTION
Experimental: Sequence ABC
Drug: Treatment A: Mavacamten intact oral capsule, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT), Treatment B: Mavacamten open capsule in suspension
Experimental: Sequence BCA
Drug: Treatment B: Mavacamten open capsule in suspension, Treatment A: Mavacamten intact oral capsule, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
Experimental: Sequence CAB
Drug: Treatment B: Mavacamten open capsule in suspension, Treatment A: Mavacamten intact oral capsule, Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)

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

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