Back to resultsAbsolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
Primary Purpose
Ulcerative Colitis
Status
Completed
Phase
Phase 1
Locations
New Zealand
Study Type
Interventional
Intervention
GS-5745 SC
GS-5745 IV
Sponsored by
About this trial
This is an interventional treatment trial for Ulcerative Colitis
Eligibility Criteria
Inclusion Criteria:
- In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination
- Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods
- Screening laboratory evaluations must be within defined thresholds
Exclusion Criteria:
- Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
- Pregnant and lactating females
- History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
GS-5745 SC
GS-5745 IV
Arm Description
Participants will receive a single dose of GS-5745 by SC injection.
Participants will receive a single dose of GS-5745 by IV infusion.
Outcomes
Primary Outcome Measures
PK profile of GS-5745
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:
Cmax: maximum observed concentration of drug in plasma
AUClast: concentration of drug from time zero to the last quantifiable concentration
AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
Secondary Outcome Measures
Incidences of adverse events and laboratory abnormalities
This composite endpoint will measure the safety and tolerability profile of GS-5745.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02209987
Brief Title
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
Official Title
A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will estimate the absolute bioavailability of subcutaneously injected GS-5745, characterize the safety, tolerability, and pharmacokinetics (PK) of GS-5745 after subcutaneous (SC) injection and intravenous (IV) administration, and evaluate the formation of anti-GS-5745 antibodies after SC and IV administration.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GS-5745 SC
Arm Type
Experimental
Arm Description
Participants will receive a single dose of GS-5745 by SC injection.
Arm Title
GS-5745 IV
Arm Type
Experimental
Arm Description
Participants will receive a single dose of GS-5745 by IV infusion.
Intervention Type
Drug
Intervention Name(s)
GS-5745 SC
Intervention Description
GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
Intervention Type
Drug
Intervention Name(s)
GS-5745 IV
Intervention Description
GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
Primary Outcome Measure Information:
Title
PK profile of GS-5745
Description
This composite endpoint will measure the plasma PK profile of GS-5745. The following parameters will be measured, where applicable:
Cmax: maximum observed concentration of drug in plasma
AUClast: concentration of drug from time zero to the last quantifiable concentration
AUC0-inf: area under the plasma concentration versus time curve starting with time zero to infinity
Time Frame
Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
Secondary Outcome Measure Information:
Title
Incidences of adverse events and laboratory abnormalities
Description
This composite endpoint will measure the safety and tolerability profile of GS-5745.
Time Frame
Up to 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In the opinion of the investigator, individuals must be in good general health based upon medical history and physical examination
Females, of childbearing potential, and males must agree to utilize protocol specific contraception methods
Screening laboratory evaluations must be within defined thresholds
Exclusion Criteria:
Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or human immunodeficiency virus (HIV)
Pregnant and lactating females
History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with individual treatment and/or adherence to the protocol
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bittoo Kanwar, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Christchurch
Country
New Zealand
12. IPD Sharing Statement
Learn more about this trial
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
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