Healthy Volunteers Clinical Trial
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
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.
| Status | Recruiting |
| Enrollment | 36 |
| Est. completion date | April 22, 2024 |
| Est. primary completion date | April 22, 2024 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years to 60 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Worldwide Clinical Trials | San Antonio | Texas |
| Lead Sponsor | Collaborator |
|---|---|
| Bristol-Myers Squibb |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Maximum observed concentration (Cmax) | Up to 37 days | ||
| Primary | Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T]) | Up to 37 days | ||
| Primary | Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72]) | Up to 37 days | ||
| Primary | Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF]) | Up to 37 days | ||
| Secondary | Time of maximum observed plasma concentration (Tmax) | Up to 37 days | ||
| Secondary | Terminal half-life (T-HALF) | Up to 37 days | ||
| Secondary | Apparent clearance (CLT/F) | Up to 37 days | ||
| Secondary | Apparent volume of distribution (Vz/F) | Up to 37 days | ||
| Secondary | Number of participants with adverse events (AEs) | Up to 37 days | ||
| Secondary | Number of participants with serious adverse events (SAEs) | Up to 37 days | ||
| Secondary | Number of participants with vital sign abnormalities | Up to 37 days | ||
| Secondary | Number of participants with electrocardiogram (ECG) findings | Up to 37 days | ||
| Secondary | Number of participants with physical examination findings | Up to 37 days | ||
| Secondary | Number of participants with abnormalities in clinical laboratory evaluations | Up to 37 days |
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