Malignancies MultiplePhase 1NCT03346837
A Study to Evaluate the Effect of 2 Drugs on the Pharmacokinetics of BMS-986205 in Healthy Subjects
A Phase 1 study testing BMS-986205, Itraconazole and Rifampin in people with Malignancies Multiple, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignancies Multiple
- What is being tested?
- BMS-986205, Itraconazole and Rifampin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2017to 20 Dec 2017
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index 18.0 to 32.0 kg/m2, inclusive
- Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
- Women must not be of childbearing potential (cannot become pregnant)
Who cannot join
- Any significant acute or chronic medical illness
- History of glucose-6-phosphodiesterase (G6PD) deficiency
- Personal or family history of cytochrome b5 reductase deficiency
- Other protocol defined inclusion / exclusion criteria could apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
Read the detailed description
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.
- Conditions
- Malignancies Multiple
- Being tested
- BMS-986205, Itraconazole, Rifampin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986205Drug
BMS-986205
ItraconazoleDrug
Oral solution
RifampinDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Inhibition (Cohort 1) | Experimental | Single oral dose BMS-986205 Receives: Drug: BMS-986205 |
| Inhibition (Cohort 2) | Experimental | Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4 Receives: Drug: BMS-986205; Drug: Itraconazole |
| Induction (Cohort 3) | Experimental | Single oral dose BMS-986205 Receives: Drug: BMS-986205 |
| Induction (Cohort 4) | Experimental | Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8 Receives: Drug: BMS-986205; Drug: Rifampin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax)
Measured by plasma concentration
Measured: Up to 25 days
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Measured by plasma concentration
Measured: Up to 25 days
AUC from time zero extrapolated to infinite time (AUC(INF))
Measured by plasma concentration
Measured: Up to 25 days
Secondary outcomes (5)
Incidence of Adverse Events (AEs)
Safety and tolerability as measured by incidence of AEs
Measured: Up to 25 days
Incidence of Serious Adverse Events (SAEs)
Safety and tolerability as measured by incidence of SAEs
Measured: Up to 76 days
Number of participants with electrocardiogram abnormalities
Measured: Up to 25 days
Number of participants with physical examination findings abnormalities
Measured: Up to 25 days
Number of participants with clinical laboratory abnormalities
Measured: Up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start22 Nov 2017
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignancies MultipleStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53 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, Briston-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03346837
- Sponsor's protocol ID
- CA017-051
- Status last verified
- Feb 2018
- First submitted
- 6 Nov 2017
- Last updated
- 28 Feb 2018
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants
- ClinicalTrials.gov ID
- NCT03346837
- Acronym / sponsor ID
- CA017-051
- Conditions
- Malignancies Multiple
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 22 Nov 2017 (actual)
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 17 Nov 2017 (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.
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
Detailed description
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Inhibition (Cohort 1) | Experimental | Drug: BMS-986205Single oral dose BMS-986205 |
| Inhibition (Cohort 2) | Experimental | Drug: BMS-986205, Drug: ItraconazoleDaily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4 |
| Induction (Cohort 3) | Experimental | Drug: BMS-986205Single oral dose BMS-986205 |
| Induction (Cohort 4) | Experimental | Drug: BMS-986205, Drug: RifampinDaily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index 18.0 to 32.0 kg/m2, inclusive
- Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
- Women must not be of childbearing potential (cannot become pregnant)
Key exclusion criteria (4 listed)
- Any significant acute or chronic medical illness
- History of glucose-6-phosphodiesterase (G6PD) deficiency
- Personal or family history of cytochrome b5 reductase deficiency
- Other protocol defined inclusion / exclusion criteria could 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-986205BMS-986205 | Drug | Induction (Cohort 3), Induction (Cohort 4), Inhibition (Cohort 1), Inhibition (Cohort 2) |
| ItraconazoleOral solution | Drug | Inhibition (Cohort 2) |
| RifampinTablet | Drug | Induction (Cohort 4) |
Primary outcome
Maximum observed plasma concentration (Cmax)
Time frame: Up to 25 days
Measured by plasma concentration
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
Time frame: Up to 25 days
Measured by plasma concentration
AUC from time zero extrapolated to infinite time (AUC(INF))
Time frame: Up to 25 days
Measured by plasma concentration
5 secondary outcomes
Incidence of Adverse Events (AEs)
Time frame: Up to 25 days
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 76 days
Number of participants with electrocardiogram abnormalities
Time frame: Up to 25 days
Number of participants with physical examination findings abnormalities
Time frame: Up to 25 days
Number of participants with clinical laboratory abnormalities
Time frame: Up to 25 days
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 28 Feb 2018.
- 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
Briston-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-986205, Itraconazole and Rifampin in people with Malignancies Multiple, 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 4 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 28 Feb 2018. 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) (time frame: Up to 25 days). The study lists 3 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 28 Feb 2018.