Healthy VolunteersPhase 1NCT03362411
A Study to Assess the Absorption of a Single Dose of BMS-986205 in Healthy Volunteers When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube, as Compared to a Tablet
A Phase 1 study testing BMS-986205 in people with Healthy Volunteers, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (NG) tube. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- BMS-986205
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Nov 2017to 1 Feb 2018
- 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
- Signed written consent form.
- Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
- Women participants must have documented proof they are not of childbearing potential.
- Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986205, and for a total of 110 days after the last dose of BMS-986205; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
- Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2).
- Body Mass Index (BMI) of 18.0 kg/m2 to 32.0 kg/m2 inclusive.
Who cannot join
- Women who are of childbearing potential or breastfeeding.
- Any significant acute or chronic illness.
- Active tuberculosis (TB) requiring treatment, documented latent TB within the previous 3 years, or evidence of a past TB infection without documented adequate therapy. All participants will be required to have a QuantiFERON -TB Gold test performed at screening.
- History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital hemolytic anemias.
- History of cardiac arrhythmias and/or autonomic instability.
- History of pulmonary, renal or liver disease.
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- History of Gilbert's Syndrome.
- Recent (within 6 months of study drug administration) history of smoking or current smokers, including use of electronic cigarettes or nicotine-containing products such as tobacco for chewing, nicotine patches, nicotine lozenges or nicotine gum.
- Participants with active, known or suspected autoimmune disease. Participants with vitiligo or psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger may enroll.
- Major surgery within 4 weeks of study drug administration.
- Other protocol defined inclusion/exclusion criteria could apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open-Label Study to Assess the Relative Bioavailability of a Single 100-mg Dose of BMS-986205 in Healthy Participants When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube Compared to an Intact Tablet of Similar Dose
The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive a single dose of BMS-986205 twice during the course of the study.
- Conditions
- Healthy Volunteers
- Being tested
- BMS-986205
- Keywords
- Healthy participants, Healthy subjects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-986205Drug
Single 100 mg dose on Day 1 and Day 15
| Study group | Role | What they receive |
|---|---|---|
| BMS-986205 intact tablet orally then crushed tablet orally | Experimental | Single, 100 mg dose Receives: Drug: BMS-986205 |
| BMS-986205 crushed tablet orally, then intact tablet orally | Experimental | Single, 100 mg dose Receives: Drug: BMS-986205 |
| BMS-986205 intact tablet orally then suspension via NG tube | Experimental | Single, 100 mg dose Receives: Drug: BMS-986205 |
| BMS-986205 suspension via NG tube then intact tablet orally | Experimental | Single, 100 mg dose Receives: Drug: BMS-986205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.
Measured by plasma concentration.
Measured: Up to 22 days
Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.
Measured by plasma concentration.
Measured: Up to 22 days
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.
Measured by plasma concentration.
Measured: Up to 22 days
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.
Measured by plasma concentration.
Measured: Up to 22 days
Secondary outcomes (5)
Incidence of non-serious Adverse Events (AEs).
Safety and tolerability as measured by incidence of non-serious AEs.
Measured: Up to 22 days
Incidence of Serious Adverse Events (SAEs).
Safety and tolerability as measured by incidence of SAEs.
Measured: Up to 22 days
Number of participants with clinical laboratory abnormalities.
Measured: Up to 22 days
Number of participants with vital sign abnormalities.
Measured: Up to 22 days
Number of participants with electrocardiogram (ECG) abnormalities.
Measured: Up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start9 Nov 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 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
- NCT03362411
- Sponsor's protocol ID
- CA017-070
- Status last verified
- Feb 2018
- First submitted
- 30 Nov 2017
- Last updated
- 23 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 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open-Label Study to Assess the Relative Bioavailability of a Single 100-mg Dose of BMS-986205 in Healthy Participants When Administered as a Crushed Tablet Orally or Crushed Tablet Suspension Via Nasogastric Tube Compared to an Intact Tablet of Similar Dose
- ClinicalTrials.gov ID
- NCT03362411
- Acronym / sponsor ID
- CA017-070
- Conditions
- Healthy Volunteers
- Keywords
- Healthy participants, Healthy subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 9 Nov 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 5 Dec 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.
The purpose of this study is to evaluate the absorption of BMS-986205 into the bloodstream of healthy volunteers, when administered as an intact tablet taken orally, or as a crushed tablet taken orally with soft food, or as a crushed tablet suspension taken via a nasogastric (NG) tube. Eligible participants will be randomly assigned to 1 of 4 treatment sequences and will receive a single dose of BMS-986205 twice during the course of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| BMS-986205 intact tablet orally then crushed tablet orally | Experimental | Drug: BMS-986205Single, 100 mg dose |
| BMS-986205 crushed tablet orally, then intact tablet orally | Experimental | Drug: BMS-986205Single, 100 mg dose |
| BMS-986205 intact tablet orally then suspension via NG tube | Experimental | Drug: BMS-986205Single, 100 mg dose |
| BMS-986205 suspension via NG tube then intact tablet orally | Experimental | Drug: BMS-986205Single, 100 mg dose |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Signed written consent form.
- Healthy male and female participants (not of childbearing potential), determined by no clinically significant deviation from normal in medical history, physical examination, ECGs (electrocardiograms) and clinical laboratory determinations.
- Women participants must have documented proof they are not of childbearing potential.
- Males sexually active with women of childbearing potential must agree to follow instructions for method(s) of contraception for duration of treatment with BMS-986205, and for a total of 110 days after the last dose of BMS-986205; and must be willing to refrain from sperm donation during this time. Azoospermic males are exempt from contraceptive requirements.
- Normal renal function at screening (Glomerula Filtration Rate ≥ 80 mL/min/1.73 m2).
Key exclusion criteria (11 listed)
- Women who are of childbearing potential or breastfeeding.
- Any significant acute or chronic illness.
- Active tuberculosis (TB) requiring treatment, documented latent TB within the previous 3 years, or evidence of a past TB infection without documented adequate therapy. All participants will be required to have a QuantiFERON -TB Gold test performed at screening.
- History of Glucose-6-Phosphate Dehydrogenase deficiency (G6PD) or any other congenital hemolytic anemias.
- History of cardiac arrhythmias and/or autonomic instability.
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-986205Single 100 mg dose on Day 1 and Day 15 | Drug | BMS-986205 crushed tablet orally, then intact tablet orally, BMS-986205 intact tablet orally then crushed tablet orally, BMS-986205 intact tablet orally then suspension via NG tube, BMS-986205 suspension via NG tube then intact tablet orally |
Primary outcome
Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.
Time frame: Up to 22 days
Measured by plasma concentration.
Maximum observed plasma concentration (Cmax) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.
Time frame: Up to 22 days
Measured by plasma concentration.
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally.
Time frame: Up to 22 days
Measured by plasma concentration.
Area under the plasma concentration time curve from time zero to 168 hours after dosing (AUC[0-168]) of single 100 mg dose of BMS-986205 administered via nasogastric (NG) tube as crushed tablet suspension compared to intact tablet administered orally.
Time frame: Up to 22 days
Measured by plasma concentration.
5 secondary outcomes
Incidence of non-serious Adverse Events (AEs).
Time frame: Up to 22 days
Incidence of Serious Adverse Events (SAEs).
Time frame: Up to 22 days
Number of participants with clinical laboratory abnormalities.
Time frame: Up to 22 days
Number of participants with vital sign abnormalities.
Time frame: Up to 22 days
Number of participants with electrocardiogram (ECG) abnormalities.
Time frame: Up to 22 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 23 Feb 2018.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Screening Protocol
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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-986205 in people with Healthy Volunteers, 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 6 inclusion and 11 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 23 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) of single 100 mg dose of BMS-986205 administered orally as crushed tablet on soft food compared to intact tablet administered orally. (time frame: Up to 22 days). The study lists 4 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 23 Feb 2018.