- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06170723
A Study to Assess the Effects of Itraconazole, Food, and pH on the Drug Levels of BMS-986368 in Healthy Participants
February 28, 2024 updated by: Celgene
A Phase 1, 2-Part, Open-Label, Fixed-Sequence Study to Evaluate the Effects of Itraconazole, Food, and pH, on the Single Dose Pharmacokinetics of BMS-986368 in Healthy Participants
This 2-part study will evaluate the effect of coadministration of a Cytochrome P450, family 3, subfamily A (CYP3A) inhibitor, itraconazole (Part 1), and a high-fat/high-calorie meal and a modified gastric pH (Part 2), on the single dose drug levels of BMS-986368 in healthy participants.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
32
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: BMS Study Connect Contact Center www.BMSStudyConnect.com
- Phone Number: 855-907-3286
- Email: Clinical.Trials@bms.com
Study Contact Backup
- Name: First line of the email MUST contain the NCT# and Site #.
Study Locations
-
-
Arizona
-
Tempe, Arizona, United States, 85283
- Local Institution - 0001
-
Contact:
- Site 0001
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) to 33.0 kg/m^2, inclusive.
Exclusion Criteria:
- Personal or first-degree family history of clinically significant psychiatric disorder, including, but not limited to, schizophrenia, psychosis, bipolar disorder, generalized anxiety disorder, obsessive-compulsive disorder, and post-traumatic stress disorder. Situational depression, or anxiety in the past, may be enrolled at the discretion of the investigator.
- Participant has an active or prior history of stroke, chronic seizures, or major neurological disorders or has first-degree family relative who was diagnosed with these disorders below the age of 65 years.
- Participant has a history of syncope and/or symptomatic orthostatic hypotension in the year prior to Day 1.
Other protocol-defined inclusion/exclusion criteria apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: BMS-986368 - Fasted
|
Specified dose on specified days
|
Experimental: Part 1: Itraconazole - Fasted
|
Specified dose on specified days
|
Experimental: Part 1: BMS-986368 with Itraconazole - Fasted
|
Specified dose on specified days
Specified dose on specified days
|
Experimental: Part 2: BMS-986368 - Fasted
|
Specified dose on specified days
|
Experimental: Part 2: BMS-986368 - Fed
|
Specified dose on specified days
|
Experimental: Part 2: Famotidine, followed by BMS-986368 - Fasted
|
Specified dose on specified days
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration (Cmax)
Time Frame: Up to 11 days
|
Up to 11 days
|
Area under the serum concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
Time Frame: Up to 11 days
|
Up to 11 days
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
Time Frame: Up to 11 days
|
Up to 11 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with clinical laboratory abnormalities
Time Frame: Up to 17 days
|
Up to 17 days
|
Number of participants with vital sign abnormalities
Time Frame: Up to 17 days
|
Up to 17 days
|
Number of participants with electrocardiogram (ECG) abnormalities
Time Frame: Up to 17 days
|
Up to 17 days
|
Number of participants with adverse events (AEs)
Time Frame: Up to 41 days
|
Up to 41 days
|
Number of participants with physical examination abnormalities
Time Frame: Up to 17 days
|
Up to 17 days
|
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Up to 17 days
|
Up to 17 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
March 15, 2024
Primary Completion (Estimated)
June 8, 2024
Study Completion (Estimated)
June 8, 2024
Study Registration Dates
First Submitted
December 6, 2023
First Submitted That Met QC Criteria
December 6, 2023
First Posted (Actual)
December 14, 2023
Study Record Updates
Last Update Posted (Estimated)
February 29, 2024
Last Update Submitted That Met QC Criteria
February 28, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Gastrointestinal Agents
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cytochrome P-450 CYP3A Inhibitors
- Cytochrome P-450 Enzyme Inhibitors
- Hormone Antagonists
- Antifungal Agents
- Steroid Synthesis Inhibitors
- Anti-Ulcer Agents
- Histamine Antagonists
- Histamine Agents
- 14-alpha Demethylase Inhibitors
- Histamine H2 Antagonists
- Itraconazole
- Famotidine
Other Study ID Numbers
- IM045-1002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria.
Additional information regarding Bristol Myers Squibb's data sharing policy and process can be found at: https://www.bms.com/researchers-and-partners/clinical-trials-and-research/disclosure-commitment.html
IPD Sharing Time Frame
See plan description
IPD Sharing Access Criteria
See plan description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Healthy Participants
-
PfizerRecruitingHealthy Subjects | Healthy ParticipantsUnited States
-
Insmed IncorporatedRecruitingHealthy ParticipantsUnited States
-
Aeovian Pharmaceuticals, Inc.RecruitingHealthy ParticipantsAustralia
-
Suzhou Zelgen Biopharmaceuticals Co.,LtdRecruitingHealthy ParticipantsChina
-
Bristol-Myers SquibbRecruiting
-
AstraZenecaParexelRecruiting
-
ProMis Neurosciences, IncRecruiting
-
Novo Nordisk A/SRecruitingHealthy ParticipantsCanada
-
Novo Nordisk A/SRecruiting
-
Alexion Pharmaceuticals, Inc.Recruiting
Clinical Trials on Itraconazole
-
University of Maryland, BaltimoreCompleted
-
University of Alabama at BirminghamWashington University School of Medicine; University of California, DavisCompletedInvasive Fungal InfectionsUnited States, Panama
-
Johns Hopkins UniversityMemorial Sloan Kettering Cancer CenterCompleted
-
Sara BotrosCompleted
-
Pulmatrix Inc.Completed
-
University of Kansas Medical CenterUniversity of Texas, Southwestern Medical Center at DallasRecruitingBarrett Oesophagitis With DysplasiaUnited States
-
Halcygen Pharmaceuticals LimitedCompletedOnychomycosisUnited States
-
H. Lundbeck A/SCompletedCytochrome P450 InteractionUnited Kingdom, United States
-
Stiefel, a GSK CompanyGlaxoSmithKlineCompletedOnychomycosisUnited States, South Africa, Canada, Dominican Republic, Ecuador, Honduras, Panama
-
Sidney Kimmel Comprehensive Cancer Center at Johns...TerminatedNon-small Cell Lung Cancer MetastaticUnited States