Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
- Conditions
- Ulcerative Colitis
- Interventions
- Drug: GS-5745 SCDrug: GS-5745 IV
- Registration Number
- NCT02209987
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description GS-5745 SC GS-5745 SC Participants will receive a single dose of GS-5745 by SC injection. GS-5745 IV GS-5745 IV Participants will receive a single dose of GS-5745 by IV infusion.
- Primary Outcome Measures
Name Time Method PK profile of GS-5745 Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8 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
Name Time Method Incidences of adverse events and laboratory abnormalities Up to 8 weeks This composite endpoint will measure the safety and tolerability profile of GS-5745.