HealthyPhase 1NCT03058822
Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial
A Phase 1 study testing BMS-931699 in people with Healthy, run by Bristol-Myers Squibb at 1 site in United States.
Trial summary
A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- BMS-931699
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2017to 30 Mar 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- All participants must have hemoglobin, hematocrit, and platelets within normal limits at screening
- All participants must have activated partial thromboplastin time, prothrombin time, and international normalized ratio within normal limits at screening
Who cannot join
- Any current or past history or risk for tuberculosis:
- Active tuberculosis requiring treatment within the previous 3 years. All participants will be required to have a QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed at screening. Also excluded are participants with evidence of a past tuberculosis infection without documented adequate therapy. Participants with a positive QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test at screening will not be eligible for the study. A QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed within 4 weeks of dosing on Day 1 is acceptable as long as there is documentation of a negative result.
- Current clinical, radiographic, or laboratory evidence of active tuberculosis
- A history of herpes zoster
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label, Parallel-group, Single Subcutaneous Dose, Relative Bioavailability Study of the Pharmacokinetics of Lulizumab (BMS-931699) From Prefilled Syringe (Process A) Compared to Drug in Vial (Process A) in Healthy Participants
A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial
- Conditions
- Healthy
- Being tested
- BMS-931699
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BMS-931699Drug
BMS-931699 single subcutaneous dose on Day 1
| Study group | Role | What they receive |
|---|---|---|
| Prefilled Syringe Upper Arm | Experimental | Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699 Receives: Drug: BMS-931699 |
| Prefilled Syringe Thigh | Experimental | Single subcutaneous dose from prefilled syringe into thigh of BMS-931699 Receives: Drug: BMS-931699 |
| Prefilled Syringe Abdomen | Experimental | Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699 Receives: Drug: BMS-931699 |
| Drug in Vial Upper Arm | Experimental | Single subcutaneous dose from drug in vial into upper arm of BMS-931699 Receives: Drug: BMS-931699 |
| Drug in Vial Thigh | Experimental | Single subcutaneous dose from drug in vial into thigh of BMS-931699 Receives: Drug: BMS-931699 |
| Drug in Vial Abdomen | Experimental | Single subcutaneous dose from drug in vial into abdomen of BMS-931699 Receives: Drug: BMS-931699 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants
Measured: 43 days
Secondary outcomes (1)
Safety and tolerability of BMS-931699 following a single prefilled syringe or drug in vial subcutaneous dose in healthy participants by assessing adverse events and other physical assessments throughout study conduct
Measured: 43 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start25 Jan 2017
- Primary completion30 Mar 2017
- Study completion30 Mar 2017
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- 5 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
- NCT03058822
- Sponsor's protocol ID
- IM128-037
- Status last verified
- Dec 2017
- First submitted
- 10 Jan 2017
- Last updated
- 20 Dec 2017
- 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 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-group, Single Subcutaneous Dose, Relative Bioavailability Study of the Pharmacokinetics of Lulizumab (BMS-931699) From Prefilled Syringe (Process A) Compared to Drug in Vial (Process A) in Healthy Participants
- ClinicalTrials.gov ID
- NCT03058822
- Acronym / sponsor ID
- IM128-037
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business objectives have changed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2017 (actual)
- Primary completion
- 30 Mar 2017 (actual)
- Study completion
- 30 Mar 2017 (actual)
- First posted
- 23 Feb 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.
A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Prefilled Syringe Upper Arm | Experimental | Drug: BMS-931699Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699 |
| Prefilled Syringe Thigh | Experimental | Drug: BMS-931699Single subcutaneous dose from prefilled syringe into thigh of BMS-931699 |
| Prefilled Syringe Abdomen | Experimental | Drug: BMS-931699Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699 |
| Drug in Vial Upper Arm | Experimental | Drug: BMS-931699Single subcutaneous dose from drug in vial into upper arm of BMS-931699 |
| Drug in Vial Thigh | Experimental | Drug: BMS-931699Single subcutaneous dose from drug in vial into thigh of BMS-931699 |
| Drug in Vial Abdomen | Experimental | Drug: BMS-931699Single subcutaneous dose from drug in vial into abdomen of BMS-931699 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms, and clinical laboratory determinations
- All participants must have hemoglobin, hematocrit, and platelets within normal limits at screening
- All participants must have activated partial thromboplastin time, prothrombin time, and international normalized ratio within normal limits at screening
Key exclusion criteria (4 listed)
- Any current or past history or risk for tuberculosis:
- Active tuberculosis requiring treatment within the previous 3 years. All participants will be required to have a QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed at screening. Also excluded are participants with evidence of a past tuberculosis infection without documented adequate therapy. Participants with a positive QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test at screening will not be eligible for the study. A QuantiFERON tuberculosis Gold or T-SPOT tuberculosis test performed within 4 weeks of dosing on Day 1 is acceptable as long as there is documentation of a negative result.
- Current clinical, radiographic, or laboratory evidence of active tuberculosis
- A history of herpes zoster
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-931699BMS-931699 single subcutaneous dose on Day 1 | Drug | Drug in Vial Abdomen, Drug in Vial Thigh, Drug in Vial Upper Arm, Prefilled Syringe Abdomen, Prefilled Syringe Thigh, Prefilled Syringe Upper Arm |
Primary outcome
Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants
Time frame: 43 days
1 secondary outcome
Safety and tolerability of BMS-931699 following a single prefilled syringe or drug in vial subcutaneous dose in healthy participants by assessing adverse events and other physical assessments throughout study conduct
Time frame: 43 days
Results and safety
The study was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- 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-931699 in people with Healthy, 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: stopped early, as of the sponsor's last update on 20 Dec 2017. 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 was stopped early (reason given: Business objectives have changed). Results are not available in the source record.
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?
Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants (time frame: 43 days). 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 20 Dec 2017.