Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
1 other identifier
interventional
28
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Aug 2014
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 4, 2014
CompletedFirst Posted
Study publicly available on registry
August 6, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 27, 2014
October 1, 2014
2 months
August 4, 2014
October 23, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
Secondary Outcomes (1)
Incidences of adverse events and laboratory abnormalities
Up to 8 weeks
Study Arms (2)
GS-5745 SC
EXPERIMENTALParticipants will receive a single dose of GS-5745 by SC injection.
GS-5745 IV
EXPERIMENTALParticipants will receive a single dose of GS-5745 by IV infusion.
Interventions
GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (1)
Unknown Facility
Christchurch, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bittoo Kanwar, MD
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 4, 2014
First Posted
August 6, 2014
Study Start
August 1, 2014
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 27, 2014
Record last verified: 2014-10