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NCT03058822

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

NCT ID: NCT03058822

Last Updated: 2017-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-25

Study Completion Date

2017-03-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Prefilled Syringe Upper Arm

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

Group Type EXPERIMENTAL

BMS-931699

Intervention Type DRUG

BMS-931699 single subcutaneous dose on Day 1

Prefilled Syringe Thigh

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

Group Type EXPERIMENTAL

BMS-931699

Intervention Type DRUG

BMS-931699 single subcutaneous dose on Day 1

Prefilled Syringe Abdomen

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

Group Type EXPERIMENTAL

BMS-931699

Intervention Type DRUG

BMS-931699 single subcutaneous dose on Day 1

Drug in Vial Upper Arm

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

Group Type EXPERIMENTAL

BMS-931699

Intervention Type DRUG

BMS-931699 single subcutaneous dose on Day 1

Drug in Vial Thigh

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

Group Type EXPERIMENTAL

BMS-931699

Intervention Type DRUG

BMS-931699 single subcutaneous dose on Day 1

Drug in Vial Abdomen

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

Group Type EXPERIMENTAL

BMS-931699

Intervention Type DRUG

BMS-931699 single subcutaneous dose on Day 1

Interventions

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BMS-931699

BMS-931699 single subcutaneous dose on Day 1

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Qps-Mra, Llc

South Miami, Florida, United States

Site Status

Countries

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United States

Related Links

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http://www.bms.com/studyconnect/pages/home.aspx

BMS Clinical Trial Education Resource

http://www.bms.com/clinical_trials/pages/investigator_inquiry_form.aspx

Investigator Inquiry Form

http://www.fda.gov/Safety/Recalls/

FDA Safety Alerts and Recalls

Other Identifiers

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IM128-037

Identifier Type: -

Identifier Source: org_study_id