Multiple Sclerosis
Conditions
Keywords
GSK2018682, First Time in Human, Healthy Volunteer
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.
Detailed description
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.
Interventions
DRUGGSK2018682
GSK2018682
DRUGPlacebo
Matched Placebo
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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).
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To investigate the safety and tolerability of single escalating oral doses of GSK2018682 | 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 | Adverse event and safety lab monitoring |
| To investigate effects of GSK2018682 on heart rate and blood pressure | 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 | 12 lead ECG and telemetry monitoring plus vital signs (systolic and diastolic blood blood pressures), heart rate, respiratory rate and temperature |
| To investigate the pharmacokinetics of single doses of GSK2018682 | 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 | Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC |
| Evaluate the effect of single escalating oral doses of GSK2018682 on lymphocytes (totals plus subsets) | 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 | Reduction from baseline in lymphocyte counts obtained at different time points after dosing and at different dose levels |
Countries
Australia
Outcome results
None listed