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

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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


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
We found this trial at
1
site
South Miami, Florida 33143
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mi
from
South Miami, FL
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