Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
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
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01431937
Registration number
NCT01431937
Ethics application status
Date submitted
11/08/2011
Date registered
12/09/2011
Date last updated
7/07/2017
Titles & IDs
Public title
Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers
Query!
Scientific title
A Single-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Ascending Doses of GSK2018682 (S1P1 Agonist) in Healthy Volunteers
Query!
Secondary ID [1]
0
0
114347
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
P1A114347
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis, Relapsing-Remitting
0
0
Query!
Condition category
Condition code
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - GSK2018682
Treatment: Drugs - Placebo
Active Comparator: GSK2018682 - Active Drug
Placebo Comparator: Placebo Control - Placebo
Treatment: Drugs: GSK2018682
Active Drug
Treatment: Drugs: Placebo
Placebo
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
To investigate the safety and tolerability of repeat oral doses of GSK2018682 in healthy volunteers (males and females of non-childbearing potential)
Query!
Assessment method [1]
0
0
Adverse event monitoring, Laboratory parameters (haematology, clinical chemistry, urinalysis), Ophthalmic examination
Query!
Timepoint [1]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [2]
0
0
To investigate effects of repeat oral doses of GSK2018682 on heart rate and blood pressure in healthy volunteers
Query!
Assessment method [2]
0
0
12-lead ECG, Telemetry ECG, Holter ECG, Vital signs (systolic and diastolic blood pressure, heart rate, respiratory rate, body temperature), Ambulatory blood pressure monitoring
Query!
Timepoint [2]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [3]
0
0
To investigate effects of repeat oral doses of GSK2018682 on lung function in healthy volunteers
Query!
Assessment method [3]
0
0
FEV1 obtained via spirometry
Query!
Timepoint [3]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [4]
0
0
To investigate the pharmacokinetics of repeat oral doses of GSK2018682 in healthy volunteers
Query!
Assessment method [4]
0
0
Peak blood concentration, Time of peak blood concentration, Area under the blood concentration-time curve over the 24-hour dose interval and area under the blood concentration-time curve from time-zero extrapolated to infinite time, Accumulation ratio, Terminal half-life, Apparent oral clearance, Through concentration
Query!
Timepoint [4]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [5]
0
0
To characterize the metabolism of GSK2018682
Query!
Assessment method [5]
0
0
GSK2018682 bile metabolites, GSK2018682 whole blood metabolites
Query!
Timepoint [5]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [6]
0
0
Evaluate the effect of repeat oral doses of GSK2018682 on lymphocytes in healthy volunteers
Query!
Assessment method [6]
0
0
% Change from baseline in absolute lymphocyte counts (ALC), % Change from baseline in subsets CD3+ [CD4+ and CD8+], CD19+, CD16+/CD56+ counts, % Change from baseline in further defined functional T cell subsets (naïve, central memory, effector memory and regulatory T cells)
Query!
Timepoint [6]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [7]
0
0
To explore the PK/PD relationship between blood concentrations and changes in vital signs and ECG parameters
Query!
Assessment method [7]
0
0
PK/PD model with parameters of the models will be determined that best describe the relationship between blood concentrations of GSK2018682 and vital signs and ECG parameters
Query!
Timepoint [7]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
Primary outcome [8]
0
0
To explore the PK/PD relationship between blood concentrations of GSK2018682 and reduction in lymphocyte counts
Query!
Assessment method [8]
0
0
PK/PD model with parameters of the models will be determined that best describe the relationship between blood concentrations of GSK2018682 and reduction ALC and subset counts CD3+ [CD4+ and CD8+], CD19+, CD16+/CD56+ and further defined functional T cell subsets (naïve, central memory, effector memory and regulatory T cells)
Query!
Timepoint [8]
0
0
Participants will be followed and monitored for the duration of their hospital stay. The longest duration of participation in the study will be approximately 13 weeks
Query!
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.
- Females must be of non-childbearing potential.
- BMI within the range 19 - 29 kg/m2 (inclusive).
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
55
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
Yes
Query!
Key exclusion criteria
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 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 regular alcohol consumption within 6 months of the study.
- 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, 5 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 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 7 days (or 14 days if the drug is a
potential enzyme inducer) or 5 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.
- Were 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 or urine hCG test at screening or
prior to dosing.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Other exclusion criteria to be detailed at the time of physical screening by the
Investigator
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
Phase 1
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
10/10/2010
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/03/2011
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
40
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Query!
Recruitment hospital [1]
0
0
GSK Investigational Site - Randwick
Query!
Recruitment hospital [2]
0
0
GSK Investigational Site - Adelaide
Query!
Recruitment hospital [3]
0
0
GSK Investigational Site - Nedlands
Query!
Recruitment postcode(s) [1]
0
0
2031 - Randwick
Query!
Recruitment postcode(s) [2]
0
0
5000 - Adelaide
Query!
Recruitment postcode(s) [3]
0
0
6009 - Nedlands
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Query!
Name
GlaxoSmithKline
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
The study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of
repeat ascending doses of GSK2018682. The study will also provide further evidence of the
potential therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on Absolute
Lymphocyte Counts (ALC).
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT01431937
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
GSK Clinical Trials
Query!
Address
0
0
GlaxoSmithKline
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01431937
Download to PDF