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

Ulcerative Colitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02209987
• Other study ID #: GS-US-326-1430
• Status: Completed
• Phase: Phase 1
• First received: August 4, 2014
• Last updated: October 23, 2014
• Start date: August 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationNew Zealand: Standing Committee on Therapeutic Trials (SCOTT)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile of GS-5745	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	No
Secondary	Incidences of adverse events and laboratory abnormalities	This composite endpoint will measure the safety and tolerability profile of GS-5745.	Up to 8 weeks	No