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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
27
GSK2018682
Matched Placebo
GSK Investigational Site
Randwick, New South Wales, Australia
GSK Investigational Site
Adelaide, South Australia, Australia
To investigate the safety and tolerability of single escalating oral doses of GSK2018682
Adverse event and safety lab monitoring
Time frame: 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
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
Time frame: 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
To investigate the pharmacokinetics of single doses of GSK2018682
Peak blood concentration, time of peak blood concentration, oral clearance, half life and AUC
Time frame: 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
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
Time frame: 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
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