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

February 29, 2024 updated by: Bristol-Myers Squibb

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain the NCT# and Site#

Study Contact Backup

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78217
        • Recruiting
        • Worldwide Clinical Trials
        • Contact:
          • Alan Hand, Site 0001
          • Phone Number: 210-635-1515

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sequence ABC
Drug: Treatment A: Mavacamten intact oral capsule
Specified dose on specified days
Drug: Treatment B: Mavacamten open capsule in suspension
Specified dose on specified days
Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
Specified dose on specified days
Experimental: Sequence BCA
Drug: Treatment A: Mavacamten intact oral capsule
Specified dose on specified days
Drug: Treatment B: Mavacamten open capsule in suspension
Specified dose on specified days
Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
Specified dose on specified days
Experimental: Sequence CAB
Drug: Treatment A: Mavacamten intact oral capsule
Specified dose on specified days
Drug: Treatment B: Mavacamten open capsule in suspension
Specified dose on specified days
Drug: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Maximum observed concentration (Cmax)
Time Frame: Up to 37 days
Up to 37 days
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
Time Frame: Up to 37 days
Up to 37 days
Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
Time Frame: Up to 37 days
Up to 37 days
Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
Time Frame: Up to 37 days
Up to 37 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time of maximum observed plasma concentration (Tmax)
Time Frame: Up to 37 days
Up to 37 days
Terminal half-life (T-HALF)
Time Frame: Up to 37 days
Up to 37 days
Apparent clearance (CLT/F)
Time Frame: Up to 37 days
Up to 37 days
Apparent volume of distribution (Vz/F)
Time Frame: Up to 37 days
Up to 37 days
Number of participants with adverse events (AEs)
Time Frame: Up to 37 days
Up to 37 days
Number of participants with serious adverse events (SAEs)
Time Frame: Up to 37 days
Up to 37 days
Number of participants with vital sign abnormalities
Time Frame: Up to 37 days
Up to 37 days
Number of participants with electrocardiogram (ECG) findings
Time Frame: Up to 37 days
Up to 37 days
Number of participants with physical examination findings
Time Frame: Up to 37 days
Up to 37 days
Number of participants with abnormalities in clinical laboratory evaluations
Time Frame: Up to 37 days
Up to 37 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 10, 2024

Primary Completion (Estimated)

April 22, 2024

Study Completion (Estimated)

April 22, 2024

Study Registration Dates

First Submitted

December 18, 2023

First Submitted That Met QC Criteria

January 8, 2024

First Posted (Actual)

January 18, 2024

Study Record Updates

Last Update Posted (Estimated)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 29, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • CV027-1070

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-andresearch/disclosure-commitment.html

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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