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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/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
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
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
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
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
Sex
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
1/08/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2014
Sample size
Target
Accrual to date
Final
28
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/ct2/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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02209987