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

Phase 1

Recruiting

• Conditions: Healthy Volunteers

• Registration Number: NCT06211179
• Lead Sponsor: Bristol-Myers Squibb

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-18
• Study First Submitted QC: 2024-01-08
• Study Start: 2024-01-10
• Study First Posted: 2024-01-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-01
• Primary Completion: 2024-04-22
• Study Completion: 2024-04-22

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Local Institution - 0001; 🇺🇸 San Antonio, Texas, United States