A Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Single-dose of Mavacamten in Healthy Participants

Phase 1CompletedNCT05320094

Bristol-Myers Squibb45 enrolled

Overview

The purpose of this study is to evaluate the effects of co-administration of activated charcoal with sorbitol on the single-dose drug levels of mavacamten in healthy participants.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Healthy Participants

Interventions

MavacamtenDRUG

Specified dose on specified days

Activated Charcoal with SorbitolDRUG

Specified dose on specified days

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index between 18 and 30 kg/m\^2, inclusive, at the Screening Visit * Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments Exclusion Criteria: * Current or recent (within 3 months of study intervention administration) gastrointestinal disease * History of sorbitol or fructose intolerance or inability to tolerate activated charcoal * History of any significant drug allergy (such as anaphylaxis or hepatotoxicity) Other protocol-defined inclusion/exclusion criteria apply

Locations (1)

Local Institution - 0001

Dallas, Texas, United States

Outcomes

Primary Outcomes

Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))

Time frame: Up to 2 months

Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T))

Time frame: Up to 2 months

Maximum observed plasma concentration (Cmax)

Time frame: Up to 1 month

Secondary Outcomes

Number of participants with adverse events (AEs)

Time frame: Up to 3 months

Number of participants with serious adverse events (SAEs)

Time frame: Up to 3 months

Number of participants with vital sign abnormalities exceeding predefined thresholds

Time frame: Up to 3 months

Number of participants with electrocardiogram (ECG) abnormalities

Time frame: Up to 3 Months

Number of participants with physical exam abnormalities

Time frame: Up to 3 months

Number of participants with clinical laboratory evaluation abnormalities

Time frame: Up to 3 months

Time of maximum observed plasma concentration (Tmax)

Time frame: Up to 1 month

Apparent terminal plasma half-life (T-HALF)

Data from ClinicalTrials.gov

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