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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01387217




Registration number
NCT01387217
Ethics application status
Date submitted
14/04/2011
Date registered
4/07/2011
Date last updated
9/06/2017

Titles & IDs
Public title
GSK2018682 FTIH in Healthy Volunteers
Scientific title
A Single-blind, Placebo-controlled, Two Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Doses of GSK2018682 in Healthy Volunteers
Secondary ID [1] 0 0
114070
Universal Trial Number (UTN)
Trial acronym
P1A114070
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK2018682
Treatment: Drugs - Placebo

Experimental: Part A - Part A will be used to confirm the prediction of GSK2018682 PK, assess its effects on lymphocytes, and monitor its safety profile in a single cohort (Cohort 1). Cohort 1 will consist of 4 subjects and explore 4 doses of GSK2018682 in 4 study sessions. In each session, three subjects will receive GSK2018682 and one subject will receive placebo. Thus, when the cohort completes, each subject will receive placebo and 3 doses of GSK2018682.

Experimental: Part B - Part B will explore doses to refine the dose-response curve of GSK2018682 on lymphocyte suppression, as allowed by stopping criteria, in 1 or 2 cohorts of up to 15 subjects (Cohort 2 and Cohort 3). In Part B, up to six single ascending doses of GSK2018682 and one dose of placebo will be investigated in up to 8 sessions.


Treatment: Drugs: GSK2018682
GSK2018682

Treatment: Drugs: Placebo
Matched Placebo

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

Outcomes
Primary outcome [1] 0 0
To investigate the safety and tolerability of single escalating oral doses of GSK2018682 - Adverse event and safety lab monitoring
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 12 weeks
Primary outcome [2] 0 0
To investigate effects of GSK2018682 on heart rate and blood pressure - 12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature
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 12 weeks
Primary outcome [3] 0 0
To investigate the pharmacokinetics of single doses of GSK2018682 - Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
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 12 weeks
Primary outcome [4] 0 0
Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets) - Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels
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 12 weeks

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
significantly 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. Subjects with lymphocyte counts outside the normal range should always be
excluded from enrollment

- BMI within the range 19 - 28 kg/m2 (inclusive).
Minimum age
18 Years
Maximum age
55 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 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

- Subjects with a history of, or examination suspicious for, skin cancer(s) including
melanoma, basal cell or squamous cell carcinoma.

- Systolic blood pressure less than 95 mmHg or greater than 140 mmHg, or diastolic blood
pressure less than or equal to 50 mmHg or greater than or equal to 95 mmHg.

- Symptomatic reduction in blood pressure after orthostatic challenge.

- Subjects with resting heart rate less than 45 beats per minute or greater than 90
beats per minute

Other criteria may apply as defined by the clinical 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Crossover
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)
NSW,SA
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment hospital [2] 0 0
GSK Investigational Site - Adelaide
Recruitment postcode(s) [1] 0 0
2031 - Randwick
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

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

Ethics approval
Ethics application status

Summary
Brief summary
This protocol describes the first administration of GSK2018682 to humans. The study will
evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending
doses of GSK2018682. The study will also provide preliminary evidence of the potential
therapeutic dose-range by measuring the inhibitory effect of GSK2018682 on total lymphocyte
counts.
Trial website
https://clinicaltrials.gov/show/NCT01387217
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

Summary results
Other publications