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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Drug: BMS-931699

• Registration Number: NCT03058822
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-10
• Study Start: 2017-01-25
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Primary Completion: 2017-03-30
• Study Completion: 2017-03-30
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-18
• Last Update Posted: 2017-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prefilled Syringe Abdomen	BMS-931699	Single subcutaneous dose from prefilled syringe into abdomen of BMS-931699
Drug in Vial Thigh	BMS-931699	Single subcutaneous dose from drug in vial into thigh of BMS-931699
Drug in Vial Abdomen	BMS-931699	Single subcutaneous dose from drug in vial into abdomen of BMS-931699
Prefilled Syringe Thigh	BMS-931699	Single subcutaneous dose from prefilled syringe into thigh of BMS-931699
Prefilled Syringe Upper Arm	BMS-931699	Single subcutaneous dose from prefilled syringe into upper arm of BMS-931699
Drug in Vial Upper Arm	BMS-931699	Single subcutaneous dose from drug in vial into upper arm of BMS-931699

Primary Outcome Measures

Name	Time	Method
Relative bioavailability of BMS-931699 following a single subcutaneous dose from prefilled syringe relative to drug in vial in healthy participants	43 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Qps-Mra, Llc; 🇺🇸 South Miami, Florida, United States