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

• Sponsor: Bristol-Myers Squibb (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05320094
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arms: 3
• Anticipated Duration (Months): 3.3
• Patients Per Site Per Month: 9.2

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Participants	Drug: Mavacamten; Drug: Activated Charcoal with Sorbitol	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten in Healthy Participants
• Actual Study Start Date: Apr 20, 2022
• Anticipated Primary Completion Date: Jul 28, 2022
• Anticipated Study Completion Date: Jul 28, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Mavacamten	Drug: Mavacamten; Specified dose on specified days
Experimental: Mavacamten and activated charcoal with sorbitol - Dose A	Drug: Mavacamten; Specified dose on specified days; Drug: Activated Charcoal with Sorbitol; Specified dose on specified days
Experimental: Mavacamten and activated charcoal with sorbitol - Dose B	Drug: Mavacamten; Specified dose on specified days; Drug: Activated Charcoal with Sorbitol; Specified dose on specified days

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF)) [Up to 2 months]

2. Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration ((AUC(0-T)) [Up to 2 months]

3. Maximum observed plasma concentration (Cmax) [Up to 1 month]

Secondary Outcome Measures

1. Number of participants with adverse events (AEs) [Up to 3 months]

2. Number of participants with serious adverse events (SAEs) [Up to 3 months]

3. Number of participants with vital sign abnormalities exceeding predefined thresholds [Up to 3 months]

4. Number of participants with electrocardiogram (ECG) abnormalities [Up to 3 Months]

5. Number of participants with physical exam abnormalities [Up to 3 months]

6. Number of participants with clinical laboratory evaluation abnormalities [Up to 3 months]

7. Time of maximum observed plasma concentration (Tmax) [Up to 1 month]

8. Apparent terminal plasma half-life (T-HALF) [Up to 2 months]

9. Concentration at 24 hours (C24) [Up to 1 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit - Dallas	Dallas	Texas	United States	75247-4989

Sponsors and Collaborators

• Bristol-Myers Squibb

Investigators

• Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

Publications

None provided.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT05320094
• Other Study ID Numbers: CV027-043
• First Posted: Apr 11, 2022
• Last Update Posted: Jul 19, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Bristol-Myers Squibb: Mavacamten; Sorbitol; Activated Charcoal
• Additional relevant MeSH terms: Sorbitol; Charcoal

Study Results

No Results Posted as of Jul 19, 2022