Healthy ParticipantsPhase 1NCT04956627
A Study to Assess the Effect of Itraconazole, Phenytoin and Gemfibrozil on the Drug Levels of BMS-986166 in Healthy Participants
A Phase 1 study testing BMS-986166, Itraconazole and Extended Phenytoin Sodium in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- BMS-986166, Itraconazole and Extended Phenytoin Sodium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jul 2021to 27 Apr 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body weight of at least 55 kg.
- Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height [m])².
- Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.
Who cannot join
- Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.
- History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.
- History of stroke or transient ischemic attacks.
- History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.
- Other protocol-defined inclusion/exclusion criteria apply
Trial locations and contacts
1 site in 1 country.
United States1 site
Hassman Research Institute
Berlin, New Jersey, 08009
About this study
Official title: A Phase 1, Single-Center, Parallel-Group, Open-Label, Randomized, Drug-Drug Interaction Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of BMS-986166 in Healthy Participants
The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.
- Conditions
- Healthy Participants
- Being tested
- BMS-986166, Itraconazole, Extended Phenytoin Sodium, Gemfibrozil
- Keywords
- Healthy Participants, BMS-986166
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986166Drug
Specified dose on specified days
ItraconazoleDrug
Also called Sporanox
Specified dose on specified days
Extended Phenytoin SodiumDrug
Also called Dilantin
Specified dose on specified days
GemfibrozilDrug
Also called Lopid
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| BMS-986166 | Experimental | Not described Receives: Drug: BMS-986166 |
| BMS-986166 + Itraconazole | Experimental | Not described Receives: Drug: BMS-986166; Drug: Itraconazole |
| BMS-986166 + Phenytoin | Experimental | Not described Receives: Drug: BMS-986166; Drug: Extended Phenytoin Sodium |
| BMS-986166 + Gemfibrozil | Experimental | Not described Receives: Drug: BMS-986166; Drug: Gemfibrozil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of BMS-986166
Measured: Up to Day 22
Cmax of BMT-121795
Measured: Up to Day 22
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Measured: Up to Day 22
Tmax of BMT-121795
Measured: Up to Day 22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166
Measured: Up to Day 22
AUC(0-T) of BMT-121795
Measured: Up to Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166
Measured: Up to Day 22
AUC(INF) of BMT-121795
Measured: Up to Day 22
Terminal plasma half-life (T-HALF) of BMS-986166
Measured: Up to Day 22
T-HALF of BMT-121795
Measured: Up to Day 22
Apparent total body clearance (CL/F) of BMS-986166
Measured: Up to Day 22
Apparent volume of distribution (Vz/F) of BMS-986166
Measured: Up to Day 22
Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)
Measured: Up to Day 22
Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))
Measured: Up to Day 22
Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))
Measured: Up to Day 22
Secondary outcomes (14)
Number of participants with Adverse Events (AEs)
Measured: Up to Day 55
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to Day 55
Number of participants with physical examination abnormalities
Measured: Up to Day 55
Number of participants with clinically significant changes in vital signs: Body temperature
Measured: Up to Day 55
Number of participants with clinically significant changes in vital signs: Respiratory rate
Measured: Up to Day 55
Number of participants with clinically significant changes in vital signs: Blood pressure
Measured: Up to Day 55
Number of participants with clinically significant changes in vital signs: Heart rate
Measured: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: PR interval
PR interval is the time from the onset of the P wave to the start of the QRS complex
Measured: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QRS
QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization
Measured: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QT interval
The QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QTcF
QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave
Measured: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Hematology tests
Measured: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Chemistry tests
Measured: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Urinalysis
Measured: Up to Day 55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2021
- Study start28 Jul 2021
- Primary completion27 Apr 2022
- Study completion27 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956627
- Sponsor's protocol ID
- IM018-004
- Status last verified
- May 2022
- First submitted
- 1 Jul 2021
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Center, Parallel-Group, Open-Label, Randomized, Drug-Drug Interaction Study to Assess the Effect of Itraconazole, Phenytoin, and Gemfibrozil on the Pharmacokinetics of a Single Oral Dose of BMS-986166 in Healthy Participants
- ClinicalTrials.gov ID
- NCT04956627
- Acronym / sponsor ID
- IM018-004
- Conditions
- Healthy Participants
- Keywords
- Healthy Participants, BMS-986166
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 27 Apr 2022 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the effect of itraconazole, phenytoin and gemfibrozil on the drug levels of BMS-986166 and its active metabolite BMT-121795. Participants will be randomly assigned to one of four groups and will remain in the study clinic for the duration of treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-986166 | Experimental | Drug: BMS-986166 |
| BMS-986166 + Itraconazole | Experimental | Drug: BMS-986166, Drug: Itraconazole |
| BMS-986166 + Phenytoin | Experimental | Drug: BMS-986166, Drug: Extended Phenytoin Sodium |
| BMS-986166 + Gemfibrozil | Experimental | Drug: BMS-986166, Drug: Gemfibrozil |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body weight of at least 55 kg.
- Body mass index (BMI) of 19.0 to 32.0 kg/m², inclusive. BMI = weight (kg)/(height [m])².
- Healthy female subjects of non-childbearing potential, or male subjects, as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations.
Key exclusion criteria (5 listed)
- Any significant acute or chronic medical illness or any other condition listed as a contraindication in the itraconazole, phenytoin, or gemfibrozil package inserts.
- History of any type of heart disease, including ischemia, infarction, clinically significant arrhythmias, sinus syndrome, hypertension, symptomatic orthostatic hypotension, atrioventricular block of any degree, bradycardia, syncope, clinically significant 12-lead ECG abnormalities, or any congenital heart disease.
- History of stroke or transient ischemic attacks.
- History of asthma or chronic obstructive pulmonary disease diagnosed or treated within the past 5 years.
- Other protocol-defined inclusion/exclusion criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BMS-986166Specified dose on specified days | Drug | BMS-986166, BMS-986166 + Gemfibrozil, BMS-986166 + Itraconazole, BMS-986166 + Phenytoin |
| ItraconazoleAlso: SporanoxSpecified dose on specified days | Drug | BMS-986166 + Itraconazole |
| Extended Phenytoin SodiumAlso: DilantinSpecified dose on specified days | Drug | BMS-986166 + Phenytoin |
| GemfibrozilAlso: LopidSpecified dose on specified days | Drug | BMS-986166 + Gemfibrozil |
Primary outcome
Maximum observed plasma concentration (Cmax) of BMS-986166
Time frame: Up to Day 22
Cmax of BMT-121795
Time frame: Up to Day 22
Time of maximum observed plasma concentration (Tmax) of BMS-986166
Time frame: Up to Day 22
Tmax of BMT-121795
Time frame: Up to Day 22
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of BMS-986166
Time frame: Up to Day 22
AUC(0-T) of BMT-121795
Time frame: Up to Day 22
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))of BMS-986166
Time frame: Up to Day 22
AUC(INF) of BMT-121795
Time frame: Up to Day 22
Terminal plasma half-life (T-HALF) of BMS-986166
Time frame: Up to Day 22
T-HALF of BMT-121795
Time frame: Up to Day 22
Apparent total body clearance (CL/F) of BMS-986166
Time frame: Up to Day 22
Apparent volume of distribution (Vz/F) of BMS-986166
Time frame: Up to Day 22
Ratio of BMT-121795 Cmax to parent Cmax corrected for molecular weight (MR_Cmax)
Time frame: Up to Day 22
Ratio of BMT-121795 AUC(0-T) to parent AUC(0-T) corrected for molecular weight (MR_AUC(0-T))
Time frame: Up to Day 22
Ratio of BMT-121795 AUC(INF) to parent AUC(INF) corrected for molecular weight (MR_AUC(INF))
Time frame: Up to Day 22
14 secondary outcomes
Number of participants with Adverse Events (AEs)
Time frame: Up to Day 55
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Day 55
Number of participants with physical examination abnormalities
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Body temperature
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Respiratory rate
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Blood pressure
Time frame: Up to Day 55
Number of participants with clinically significant changes in vital signs: Heart rate
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: PR interval
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QRS
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QT interval
Time frame: Up to Day 55
Number of participants with clinically significant changes in ECG parameters: QTcF
Time frame: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Hematology tests
Time frame: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Chemistry tests
Time frame: Up to Day 55
Number of participants with clinically significant changes in laboratory values: Urinalysis
Time frame: Up to Day 55
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- Investigator Inquiry FormLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BMS-986166, Itraconazole and Extended Phenytoin Sodium in people with Healthy Participants, run by Bristol-Myers Squibb at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum observed plasma concentration (Cmax) of BMS-986166 (time frame: Up to Day 22). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.