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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00996671




Trial ID
NCT00996671
Ethics application status
Date submitted
15/10/2009
Date registered
15/10/2009
Date last updated
13/06/2017

Titles & IDs
Public title
Phase I Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of GSK2256098 in Healthy Volunteers
Scientific title
A Phase I, Randomized, Single-Blind, Placebo-Controlled Dose-Escalation Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics and Preliminary Food Effect Following Single Oral Doses of the Focal Adhesion Kinase Inhibitor, GSK2256098, in Healthy Subjects
Secondary ID [1] 0 0
113581
Universal Trial Number (UTN)
Trial acronym
FTIH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK2256098
Treatment: Drugs - Placebo

Experimental: Dose Escalation Cohorts - single dose administration escalating doses starting at 20 mg and continue escalation; the highest dose in this study will not exceed the mean Day 1 exposure in male dogs at the NOAEL dose (6 mg/kg/day).

Experimental: Food effect Cohort - Dose to be selected based on emerging safety and PK data; subjects will be given FDA standard high fat meal followed by single dose of study drug.


Treatment: Drugs: GSK2256098
focal adhesion kinase inhibitor given as a single dose

Treatment: Drugs: Placebo
Placebo to be used as comparator for GSK2256098

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

Outcomes
Primary outcome [1] 0 0
To characterize the safety of single doses of GSK2256098 in adult healthy subjects
Timepoint [1] 0 0
within 10-14 days following administration of study drug
Primary outcome [2] 0 0
To characterize the single dose pharmacokinetics of GSK2256098 in blood and urine in adult healthy subjects
Timepoint [2] 0 0
14 days after administration of study drug
Secondary outcome [1] 0 0
To examine the dose proportionality of GSK2256098 pharmacokinetic parameters following single dose administration in healthy subjects
Timepoint [1] 0 0
14 days
Secondary outcome [2] 0 0
To explore dose- and concentration-effect relationships for various safety parameters, if appropriate
Timepoint [2] 0 0
14 days
Secondary outcome [3] 0 0
To estimate the effect of high fat/calorie meal on the pharmacokinetics, safety, and tolerability of a single dose of GSK2256098.
Timepoint [3] 0 0
14 days
Secondary outcome [4] 0 0
To explore and potentially identify small molecules or cytokines in plasma which may serve as biomarkers for future studies
Timepoint [4] 0 0
14 days

Eligibility
Key inclusion criteria
- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring. A subject with a clinical abnormality or laboratory parameters
outside the reference range for the population being studied may be included only if
the Investigator and the GSK Medical Monitor agree that the finding is unlikely to
introduce additional risk factors and will not interfere with the study procedures.

- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5 X ULN (isolated
bilirubin >1.5 X ULN is acceptable if bilirubin is fractionated and direct bilirubin <
35%).

- Urine microalbumin: creatinine ratio < 300 mg/g.

- Male or female between 18 and 65 years of age inclusive, at the time of signing the
informed consent.

- female subject is eligible to participate if she is of: Non-childbearing potential
defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or
postmenopausal defined as 12 months of spontaneous amenorrhea [in questionable cases a
blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and
estradiol < 40 pg/ml (<140 pmol/L) is confirmatory].

- Male subjects must agree to use one of the contraception methods listed in Section
8.1. This criterion must be followed from the time of the first dose of study
medication until the end of the follow-up period.

- Body weight greater than or equal to 50 kg and body mass index (BMI) within the range
18.5 to 30.0 kg/m2 (inclusive).

- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

- Average QTcF < 450 msec (based on averaged results of three ECGs).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within three months of screening.

- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).

- A positive pre-study drug/alcohol screen.

- A positive test for HIV antibody.

- History of alcohol consumption within six months of the study defined as:

an average weekly intake of > 21 units for males or > 14 units for females. One unit is
equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1
(25 ml) measure of spirits.

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, five half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).

- Exposure to more than four new chemical entities or investigational products within 12
months prior to the first dosing day.

- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements (including St John's Wort) within seven days (or 14 days if the drug is a
potential enzyme inducer) or five half-lives (whichever is longer) prior to the first
dose of study medication, unless in the opinion of the Investigator and GSK Medical
Monitor the medication will not interfere with the study procedures or compromise
subject safety.

- History of sensitivity to any of the study medications, or components thereof or a
history of drug or other allergy that, in the opinion of the Investigator or GSK
Medical Monitor, contraindicates their participation.

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

- Pregnant females as determined by positive serum hCG test at screening or positive
urine hCG test prior to dosing.

- Lactating females.

- Unwillingness or inability to follow the procedures outlined in the protocol.

- Subject is mentally or legally incapacitated.

- History of sensitivity to heparin or heparin-induced thrombocytopenia.

- Subjects who have asthma or a history of asthma or reactive airway disease.

- History of regular tobacco use or nicotine containing products within three months
prior to screening or a positive urine cotinine test result indicative of smoking at
screening.

- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or
kumquats, pummelos, exotic citrus fruit (i.e., star fruit, bitter melon), grapefruit
hybrids or fruit juices from seven days prior to the first dose of study medication.

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Single group
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)
VIC
Recruitment hospital [1] 0 0
GSK Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

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

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to test the safety of a new drug and to look at how the drug is
handled by your body. This is the first time the drug will be given to people, the drug has
been safely given to animals over many days at higher doses than will be given in the study.
The study will be done in healthy men and woman to determine what effects, good or bad, it
has on thier health. This study will find out:

If the drug has any side effects after one dose of the drug is given? How much of the drug
gets into the bloodstream, and how long does the body take to get rid of it? If the drug
causes any changes to a substance that is in skin, hair or blood.
Trial website
https://clinicaltrials.gov/show/NCT00996671
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
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