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

NCT06211179 | Completed Phase 1 FDA Drug

• 1 other identifier: CV027-1070
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Maximum observed concentration (Cmax)

  Up to 37 days

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

  Up to 37 days

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

  Up to 37 days

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

  Up to 37 days

Secondary Outcomes (10)

• Time of maximum observed plasma concentration (Tmax)

  Up to 37 days

• Terminal half-life (T-HALF)

  Up to 37 days

• Apparent clearance (CLT/F)

  Up to 37 days

• Apparent volume of distribution (Vz/F)

  Up to 37 days

• Number of participants with adverse events (AEs)

  Up to 37 days

Study Arms (3)

Sequence ABC

EXPERIMENTAL

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

Sequence BCA

EXPERIMENTAL

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

Sequence CAB

EXPERIMENTAL

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

Interventions

Treatment A: Mavacamten intact oral capsule DRUG

Specified dose on specified days

Sequence ABC; Sequence BCA; Sequence CAB

Treatment B: Mavacamten open capsule in suspension DRUG

Specified dose on specified days

Sequence ABC; Sequence BCA; Sequence CAB

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

Specified dose on specified days

Sequence ABC; Sequence BCA; Sequence CAB

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Local Institution - 0001

San Antonio, Texas, 78217, United States

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 18, 2024
• Study Start: January 10, 2024
• Primary Completion: June 13, 2024
• Study Completion: June 13, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)