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Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02209987
Recruitment Status : Completed
First Posted : August 6, 2014
Last Update Posted : October 27, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: GS-5745 SC Drug: GS-5745 IV Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: GS-5745 SC
Participants will receive a single dose of GS-5745 by SC injection.
Drug: GS-5745 SC
GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe

Experimental: GS-5745 IV
Participants will receive a single dose of GS-5745 by IV infusion.
Drug: GS-5745 IV
GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials




Primary Outcome Measures :
  1. PK profile of GS-5745 [ Time Frame: 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 :
  1. Incidences of adverse events and laboratory abnormalities [ Time Frame: Up to 8 weeks ]
    This composite endpoint will measure the safety and tolerability profile of GS-5745.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02209987


Locations
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New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Bittoo Kanwar, MD Gilead Sciences

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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02209987     History of Changes
Other Study ID Numbers: GS-US-326-1430
First Posted: August 6, 2014    Key Record Dates
Last Update Posted: October 27, 2014
Last Verified: October 2014

Additional relevant MeSH terms:
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Colitis, Ulcerative
Colitis
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Inflammatory Bowel Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs