Irritable Bowel Syndrome Clinical Trial
Official title:
A Phase 1, Randomized, Placebo-Controlled, Double-Blind, Ascending Dose Escalating, 4 Period Crossover Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Food Effect of Single Doses of GSK3179106, a REarranged During Transfection (RET) Growth Factor Receptor Tyrosine Kinase Inhibitor, in Normal Healthy Volunteers
GSK3179106 is a potent and relatively selective inhibitor of RET kinase which has been
designed to be a safe and effective therapy for irritable bowel syndrome (IBS) patients .
This is a randomized, double-blind (sponsor unblind), placebo-controlled, dose escalating,
four period, single-dose crossover, first time in human study to assess the safety,
tolerability and pharmacokinetics of GSK3179106 in normal healthy subjects.
The study will be composed of 2 cohorts, each having screening (21 days prior to first dose
of study drug), Treatment, and follow-up periods (7-10 days after their last dose [Day 1 of
dosing period 4]). The Treatment period will include 4 dosing periods. Subjects will
participate in either Cohort 1 or Cohort 2. The total duration of the study for each subject
will be approximately 10 weeks. A sufficient number of healthy subjects will be screened to
enrol 16 subjects who complete the planned study procedures. Each dosing period will be
staggered so that only 2 of the 8 subjects will be administered study drug initially. Once
24 hours (h) have elapsed, and provided there are no safety concerns, the remainder of
subjects scheduled for that dosing period may be dosed. A review of safety and tolerability
will occur prior to administration of the next dose level. This same procedure will be
followed for each escalating dosing period. Subjects assigned to Cohort 1 will participate
in 1 placebo and 3 dose escalating periods. Subjects assigned to Cohort 2 will participate
in up to 4 dosing periods which include up to 2 escalating doses and placebo in Periods 1
and 2, and a pilot food effect in Periods 3 and 4. Within each cohort, subjects will return
for their next scheduled dosing period approximately 14 days after administration of the
study drug during the prior dosing period. Cohort 2 will proceed after completion of the
treatment periods in Cohort 1. Each subject will be enrolled in only one cohort. The planned
dose range is 10 milligram (mg) to 200 mg in Cohort 1. The actual doses to be administered
may be adjusted based on safety, tolerability, and pharmacokinetic data at previous dose
levels; these dose adjustments may involve either an increase or a decrease in the planned
dose for both Cohorts 1 and 2. There are no formal hypotheses being tested in this study.
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