Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial
Status: | Terminated |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 45 |
Updated: | 12/22/2017 |
Start Date: | January 25, 2017 |
End Date: | March 30, 2017 |
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
drug in vial
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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