This study is the First Time In Human study for the motilin receptor agonist, GSK1322888. GSK1322888 is a potent and selective small molecule motilin receptor agonist, distinct from the motilide compound structures. The aims of this study are to assess the safety, tolerance, and pharmacokinetics of single oral doses of GSK1322888 and to identify a well-tolerated and safe dose that will accelerate gastric emptying of a 13C stable isotope-labeled test meal in healthy volunteers. The study will include assessment of ECGs, vital signs, safety laboratory sampling, adverse events, pharmacokinetics, and the 13C-Octanoic Acid Breath Test to measure gastric emptying.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
17
1 mg, 5 mg or 25 mg capsule
matching placebo capsules
GSK Investigational Site
Randwick, New South Wales, Australia
Adverse Events following single oral doses of GSK1322888
includes abnormal clincal lab values, ECGs, vital signs
Time frame: 1 week post dose
pharmacokinetics of GSK1322888 following single, oral doses
includes AUC, Cmax, tmax, and t1/2
Time frame: 48 h post dose
gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888
includes gastric half emptying time, gastric emptying coefficient
Time frame: 4 h
dose/exposure response relationship for gastric emptying of a radio-labeled test meal, as measured by the 13C-octanoic acid breath test following single oral doses of GSK1322888
dose response of GSK1322888 on gastric emptying
Time frame: 48 h
dose proportionality following single dose administration
Time frame: 48 h
steady-state PK based on single dose data
Time frame: 28 h
accumulation based on single dose data
Time frame: 48 h
ethnicity differences in safety, tolerability, pharmacokinetics, and pharmacodynamics between volunteers of Caucasian or Japanese ethnicity
difference in adverse events between ethnicities
Time frame: 1 week
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