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Sequence ABC for Healthy Subjects

Phase 1
Recruiting
Research Sponsored by Bristol-Myers Squibb
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 37 days
Awards & highlights

Study Summary

This trial is trying to find out if there is a difference in how the body absorbs a medication called Mavacamten when it is taken as a pill or through a tube in healthy people.

Who is the study for?
This trial is for healthy individuals with a body mass index (BMI) between 18 and 32 kg/m2. Participants must be able to follow the study's rules and restrictions, as determined by physical exams, vital signs, ECGs, and lab tests.Check my eligibility
What is being tested?
The study is testing how well the body absorbs Mavacamten when given as an open capsule in suspension through a nasogastric tube compared to swallowing it as an intact oral capsule.See study design
What are the potential side effects?
Since this trial involves healthy volunteers and focuses on bioavailability rather than treatment effects or efficacy, specific side effects are not detailed but may include discomfort from NGT administration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 37 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 37 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
+1 more
Secondary outcome measures
Apparent clearance (CLT/F)
Apparent volume of distribution (Vz/F)
Number of participants with abnormalities in clinical laboratory evaluations
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Sequence CABExperimental Treatment3 Interventions
Group II: Sequence BCAExperimental Treatment3 Interventions
Group III: Sequence ABCExperimental Treatment3 Interventions

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Bristol-Myers SquibbLead Sponsor
2,639 Previous Clinical Trials
4,128,996 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Which individuals are eligible to participate in this research investigation?

"To be eligible for enrollment in this trial, prospective participants must meet the criteria of being healthy individuals aged between 18 and 60. The study aims to recruit approximately 36 patients."

Answered by AI

What is the current capacity for patient enrollment in this clinical trial?

"Indeed, as stated on clinicaltrials.gov, this ongoing study is currently seeking eligible participants. The trial was initially posted on February 7th, 2024 and last updated on January 19th, 2024. A total of 36 patients will be enrolled at a single site for the duration of the trial."

Answered by AI

Are there ongoing efforts to actively enroll participants in this trial?

"Indeed, the data available on clinicaltrials.gov indicates that this particular trial is presently in the process of enrolling participants. The study was initially posted on February 7th, 2024 and underwent its most recent update on January 19th, 2024. A total of 36 patients will be admitted to a single site as part of this trial."

Answered by AI

Is the age range of individuals under 25 years old considered suitable for participation in this medical study?

"To be eligible for enrollment in this clinical trial, participants must meet the age criteria of being at least 18 years old but not exceeding 60 years old."

Answered by AI

Has the FDA granted its approval to Sequence ABC for medical use?

"Since this is a Phase 1 trial, the safety of Sequence ABC has been estimated as 1 on a scale from 1 to 3. This indicates that there is limited data available regarding both safety and efficacy at this stage."

Answered by AI

Who else is applying?

What site did they apply to?
Worldwide Clinical Trials
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

~24 spots leftby Apr 2025