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Completed

NCT Number: NCT02209987

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

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.

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Key information

Conditions

Ulcerative Colitis Colitis Colitis, Ulcerative Colonic Diseases Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Christchurch, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GS-5745 SC

Drug

GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe

GS-5745 IV

Drug

GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 6, 2014
Registry last updated
Oct 27, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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