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

October 23, 2014 updated by: Gilead Sciences

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gilead Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 4, 2014

First Submitted That Met QC Criteria

August 4, 2014

First Posted (Estimate)

August 6, 2014

Study Record Updates

Last Update Posted (Estimate)

October 27, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-326-1430

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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