Status:
COMPLETED
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
Lead Sponsor:
Gilead Sciences
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2014
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02209987
Start Date
August 1 2014
End Date
October 1 2014
Last Update
October 27 2014
Active Locations (1)
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1
Christchurch, New Zealand