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Part 2: Famotidine, followed by BMS-986368 - Fasted for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Celgene

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) to 33.0 kg/m^2, inclusive.

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 41 days

Awards & highlights

Study Summary

This trial will look at how taking a medication called itraconazole along with a high-fat meal and a change in stomach acidity affects the levels of another drug called BMS-986368 in healthy

Who is the study for?

This trial is for healthy individuals with a BMI between 18.0 and 33.0 kg/m^2. It's not suitable for those outside this weight range or who have health conditions that could interfere with the study.Check my eligibility

What is being tested?

The study is testing how BMS-986368 levels change when taken with itraconazole (a drug affecting liver enzymes) or after eating a high-fat meal and altering stomach acidity.See study design

What are the potential side effects?

Possible side effects may include issues related to the digestive system, like nausea or constipation, due to itraconazole, and changes in stomach pH from famotidine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 41 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 41 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 41 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 plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])

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

Maximum observed plasma concentration (Cmax)

Secondary outcome measures

Columbia-Suicide Severity Rating Scale (C-SSRS)

Number of participants with adverse events (AEs)

Number of participants with clinical laboratory abnormalities

+3 more

Trial Design

6Treatment groups

Experimental Treatment

Group I: Part 2: Famotidine, followed by BMS-986368 - FastedExperimental Treatment2 Interventions

Group II: Part 2: BMS-986368 - FedExperimental Treatment1 Intervention

Group III: Part 2: BMS-986368 - FastedExperimental Treatment1 Intervention

Group IV: Part 1: Itraconazole - FastedExperimental Treatment1 Intervention

Group V: Part 1: BMS-986368 with Itraconazole - FastedExperimental Treatment2 Interventions

Group VI: Part 1: BMS-986368 - FastedExperimental Treatment1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Famotidine

2005

Completed Phase 4

~1700

Itraconazole

2017

Completed Phase 2

~780

0 / 1Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

CelgeneLead Sponsor

637 Previous Clinical Trials

129,482 Total Patients Enrolled

Bristol-Myers SquibbStudy DirectorBristol-Myers Squibb

1,510 Previous Clinical Trials

3,371,093 Total Patients Enrolled

Frequently Asked Questions

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

Does this study allow individuals who are at least 18 years old to participate?

"To be considered eligible for this clinical trial, individuals must be at least 18 years old but no older than 55."

Answered by AI

Has Part 1: Itraconazole - Fasted been officially endorsed by the FDA?

"Given that this trial is in Phase 1 with limited safety and efficacy data available, our team rates the safety of Part 1: Itraconazole - Fasted as a 1."

Answered by AI

Are there any available vacancies for patient participation in this clinical trial?

"As per information on clinicaltrials.gov, this specific medical trial is presently not seeking new participants. Its initial posting was on March 15, 2024, with the most recent update done on February 28, 2024. While recruitment for this study is paused currently, it's noteworthy that there are a total of 795 ongoing trials actively looking for eligible candidates."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants

2024. "A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06170723.