The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02209987




Registration number
NCT02209987
Ethics application status
Date submitted
4/08/2014
Date registered
6/08/2014
Date last updated
27/10/2014

Titles & IDs
Public title
Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Adults
Scientific title
A Phase 1 Study to Evaluate the Absolute Bioavailability, Safety, and Tolerability of Subcutaneous GS-5745 in Healthy Subjects
Secondary ID [1] 0 0
GS-US-326-1430
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ulcerative Colitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GS-5745 SC
Treatment: Drugs - GS-5745 IV

Experimental: GS-5745 SC - Participants will receive a single dose of GS-5745 by SC injection.

Experimental: GS-5745 IV - Participants will receive a single dose of GS-5745 by IV infusion.


Treatment: Drugs: 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

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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Predose and postdose on Days 1 and Day 11, and Weeks 2, 3, 4, 6, and 8
Secondary outcome [1] 0 0
Incidences of adverse events and laboratory abnormalities - This composite endpoint will measure the safety and tolerability profile of GS-5745.
Timepoint [1] 0 0
Up to 8 weeks

Eligibility
Key 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
Minimum age
18 Years
Maximum age
45 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT02209987
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bittoo Kanwar, MD
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications