Clinical trial NCT06211179: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2024-01-18
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Maximum observed concentration (Cmax)
timeFrame: Up to 37 days
measure: Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
timeFrame: Up to 37 days
measure: Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
timeFrame: Up to 37 days
measure: Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
timeFrame: Up to 37 days
Secondary outcomes:
measure: Time of maximum observed plasma concentration (Tmax)
timeFrame: Up to 37 days
measure: Terminal half-life (T-HALF)
timeFrame: Up to 37 days
measure: Apparent clearance (CLT/F)
timeFrame: Up to 37 days
measure: Apparent volume of distribution (Vz/F)
timeFrame: Up to 37 days
measure: Number of participants with adverse events (AEs)
timeFrame: Up to 37 days
measure: Number of participants with serious adverse events (SAEs)
timeFrame: Up to 37 days
measure: Number of participants with vital sign abnormalities
timeFrame: Up to 37 days
measure: Number of participants with electrocardiogram (ECG) findings
timeFrame: Up to 37 days
measure: Number of participants with physical examination findings
timeFrame: Up to 37 days
measure: Number of participants with abnormalities in clinical laboratory evaluations
timeFrame: Up to 37 days
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: Local Institution - 0001
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: