Healthy Volunteers
Conditions
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.
Interventions
DRUGTreatment A: Mavacamten intact oral capsule
Specified dose on specified days
DRUGTreatment B: Mavacamten open capsule in suspension
Specified dose on specified days
DRUGTreatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT)
Specified dose on specified days
Sponsors
Bristol-Myers Squibb
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Time of maximum observed plasma concentration (Tmax) | 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 |
| Number of participants with electrocardiogram (ECG) findings | 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 |
Countries
United States
Outcome results
None listed