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

December 18, 2017 updated by: Bristol-Myers Squibb

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • South Miami, Florida, United States, 33143
        • Qps-Mra, Llc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prefilled Syringe Upper Arm
Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699
Drug: BMS-931699
BMS-931699 single subcutaneous dose on Day 1
Experimental: Prefilled Syringe Thigh
Single subcutaneous dose from prefilled syringe into thigh of BMS-931699
Drug: BMS-931699
BMS-931699 single subcutaneous dose on Day 1
Experimental: Prefilled Syringe Abdomen
Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699
Drug: BMS-931699
BMS-931699 single subcutaneous dose on Day 1
Experimental: Drug in Vial Upper Arm
Single subcutaneous dose from drug in vial into upper arm of BMS-931699
Drug: BMS-931699
BMS-931699 single subcutaneous dose on Day 1
Experimental: Drug in Vial Thigh
Single subcutaneous dose from drug in vial into thigh of BMS-931699
Drug: BMS-931699
BMS-931699 single subcutaneous dose on Day 1
Experimental: Drug in Vial Abdomen
Single subcutaneous dose from drug in vial into abdomen of BMS-931699
Drug: BMS-931699
BMS-931699 single subcutaneous dose on Day 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
43 days

Secondary Outcome Measures

Outcome Measure
Time Frame
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
43 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2017

Primary Completion (Actual)

March 30, 2017

Study Completion (Actual)

March 30, 2017

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

February 16, 2017

First Posted (Actual)

February 23, 2017

Study Record Updates

Last Update Posted (Actual)

December 20, 2017

Last Update Submitted That Met QC Criteria

December 18, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • IM128-037

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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