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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02209987 |
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Date of registration:
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04/08/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
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Scientific title:
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A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects |
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Date of first enrolment:
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August 2014 |
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Target sample size:
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28 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02209987 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1
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Countries of recruitment
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New Zealand
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Contacts
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Name:
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Bittoo Kanwar, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gilead Sciences |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Drug: GS-5745 IV
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Drug: GS-5745 SC
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Primary Outcome(s)
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PK profile of GS-5745
[Time Frame: Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8]
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Secondary Outcome(s)
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Incidences of adverse events and laboratory abnormalities
[Time Frame: Up to 8 weeks]
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Secondary ID(s)
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GS-US-326-1430
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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