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

NCT03058822 | Terminated Phase 1 FDA Drug

• 1 other identifier: IM128-037
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants

  43 days

Secondary Outcomes (1)

• 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

  43 days

Study Arms (6)

Prefilled Syringe Upper Arm

EXPERIMENTAL

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

Drug: BMS-931699

Prefilled Syringe Thigh

EXPERIMENTAL

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

Drug: BMS-931699

Prefilled Syringe Abdomen

EXPERIMENTAL

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

Drug: BMS-931699

Drug in Vial Upper Arm

EXPERIMENTAL

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

Drug: BMS-931699

Drug in Vial Thigh

EXPERIMENTAL

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

Drug: BMS-931699

Drug in Vial Abdomen

EXPERIMENTAL

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

Drug: BMS-931699

Interventions

BMS-931699 DRUG

BMS-931699 single subcutaneous dose on Day 1

Drug in Vial Abdomen; Drug in Vial Thigh; Drug in Vial Upper Arm; Prefilled Syringe Abdomen; Prefilled Syringe Thigh; Prefilled Syringe Upper Arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (1)

Qps-Mra, Llc

South Miami, Florida, 33143, United States

Location

Related Links

• BMS Clinical Trial Education Resource
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

lulizumab pegol

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: February 23, 2017
• Study Start: January 25, 2017
• Primary Completion: March 30, 2017
• Study Completion: March 30, 2017
• Last Updated: December 20, 2017

Record last verified: 2017-12

Locations

US (1)