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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03058822
• Other study ID #: IM128-037
• Status: Terminated
• Phase: Phase 1
• First received: January 10, 2017
• Last updated: December 18, 2017
• Start date: January 25, 2017
• Est. completion date: March 30, 2017

Study information

• Verified date: December 2017
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 30, 2017
• Est. primary completion date: March 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• BMS-931699
BMS-931699 single subcutaneous dose on Day 1

Locations

Country	Name	City	State
United States	Qps-Mra, Llc	South Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants		43 days
Secondary	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

External Links

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