Relative Bioavailability of BMS-931699 From Prefilled Syringe Compared to Drug in Vial

Bristol-Myers Squibb (BMS)

Status and phase: Terminated; Phase 1

Conditions: Healthy

Treatments: Drug: BMS-931699

Study type: Interventional

Funder types: Industry

Identifiers

NCT03058822

IM128-037

Details and patient eligibility

About

A Phase 1, relative bioavailability study of BMS-931699 from prefilled syringe compared to drug in vial

Enrollment: 5 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 6 patient groups

Prefilled Syringe Upper Arm

Experimental group

Description:

Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699

Treatment:

Drug: BMS-931699

Prefilled Syringe Thigh

Experimental group

Description:

Single subcutaneous dose from prefilled syringe into thigh of BMS-931699

Treatment:

Drug: BMS-931699

Prefilled Syringe Abdomen

Experimental group

Description:

Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699

Treatment:

Drug: BMS-931699

Drug in Vial Upper Arm

Experimental group

Description:

Single subcutaneous dose from drug in vial into upper arm of BMS-931699

Treatment:

Drug: BMS-931699

Drug in Vial Thigh

Experimental group

Description:

Single subcutaneous dose from drug in vial into thigh of BMS-931699

Treatment:

Drug: BMS-931699

Drug in Vial Abdomen

Experimental group

Description:

Single subcutaneous dose from drug in vial into abdomen of BMS-931699

Treatment:

Drug: BMS-931699