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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT); Drug: Treatment A: Mavacamten intact oral capsule; Drug: Treatment B: Mavacamten open capsule in suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT06211179

CV027-1070

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 3 patient groups

Sequence ABC

Experimental group

Treatment:

Drug: Treatment B: Mavacamten open capsule in suspension

Drug: Treatment A: Mavacamten intact oral capsule

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

Sequence BCA

Experimental group

Treatment:

Drug: Treatment B: Mavacamten open capsule in suspension

Drug: Treatment A: Mavacamten intact oral capsule

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

Sequence CAB

Experimental group

Treatment:

Drug: Treatment B: Mavacamten open capsule in suspension

Drug: Treatment A: Mavacamten intact oral capsule

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